Trial Outcomes & Findings for EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions (NCT NCT01435031)

Last Updated: 2018-05-09

Results Overview

The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.

Recruitment status

COMPLETED

Study phase

Target enrollment

250 participants

Primary outcome timeframe

1 year

Results posted on

2018-05-09

Participant Flow

A total of 250 subjects were enrolled in 20 sites from September 13, 2011 to February 7, 2013. Twenty-eight participants were excluded from ITT (N=222) in whom recanalization and pre-dilatation of the target lesion were not completed and/or study stent was not inserted into the coronary guiding catheter.

ITT set included 222 subjects who met entry criteria, were enrolled in the trial and whose target lesion was successfully crossed and predilated. PP set included all ITT subjects (N = 183) in whom at least 1 study stent was implanted,met procedure success,had follow-up data and had no major protocol deviations due to inappropriate enrollment.

Participant milestones

Participant milestones
Measure	CTO Treatment Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
ITT at 1 Month STARTED	222
ITT at 1 Month COMPLETED	216
ITT at 1 Month NOT COMPLETED	6
ITT at 6 Months STARTED	216
ITT at 6 Months COMPLETED	211
ITT at 6 Months NOT COMPLETED	5
ITT at 1 Year STARTED	211
ITT at 1 Year COMPLETED	202
ITT at 1 Year NOT COMPLETED	9
ITT at 2 Years STARTED	202
ITT at 2 Years COMPLETED	189
ITT at 2 Years NOT COMPLETED	13
ITT at 3 Years STARTED	189
ITT at 3 Years COMPLETED	178
ITT at 3 Years NOT COMPLETED	11
ITT at 4 Years STARTED	178
ITT at 4 Years COMPLETED	171
ITT at 4 Years NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	CTO Treatment Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
ITT at 1 Month Withdrawal by Subject	1
ITT at 1 Month Death	1
ITT at 1 Month Lost to Follow-up	4
ITT at 6 Months Death	2
ITT at 6 Months Lost to Follow-up	3
ITT at 1 Year Death	1
ITT at 1 Year Withdrawal by Subject	2
ITT at 1 Year Lost to Follow-up	6
ITT at 2 Years Death	7
ITT at 2 Years Withdrawal by Subject	2
ITT at 2 Years Lost to Follow-up	4
ITT at 3 Years Death	5
ITT at 3 Years Withdrawal by Subject	2
ITT at 3 Years Lost to Follow-up	4
ITT at 4 Years Death	4
ITT at 4 Years Withdrawal by Subject	2
ITT at 4 Years Lost to Follow-up	1

Baseline Characteristics

EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Age, Continuous	61.65 years STANDARD_DEVIATION 10.43 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	180 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	178 Participants n=5 Participants
Race (NIH/OMB) More than one race	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	222 participants n=5 Participants
Clinical Characteristics Prior Myocardial Infarction (MI)	61 participants n=5 Participants
Clinical Characteristics Previous Percutaneous Intervention (PCI)	96 participants n=5 Participants
Clinical Characteristics Prior Coronary Artery Bypass Graft Surgery	22 participants n=5 Participants
Clinical Characteristics Transient Ischemic Attack (TIA)	3 participants n=5 Participants
Clinical Characteristics Stroke	2 participants n=5 Participants
Clinical Characteristics Congestive Heart Failure	27 participants n=5 Participants
Clinical Characteristics Diabetes Mellitus	89 participants n=5 Participants
Clinical Characteristics Hypertension	203 participants n=5 Participants
Clinical Characteristics Dyslipidemia	215 participants n=5 Participants
Clinical Characteristics Renal Insufficiency/failure	1 participants n=5 Participants
Clinical Characteristics Atrial fibrillation	14 participants n=5 Participants
Clinical Characteristics History of bleeding	18 participants n=5 Participants
Clinical Characteristics Cancer	4 participants n=5 Participants
Clinical Characteristics Mental Illness	5 participants n=5 Participants
Tobacco use Never used tobacco	65 participants n=5 Participants
Tobacco use Former user, quit more than 1 month ago	89 participants n=5 Participants
Tobacco use Current or former, quit within the past month	54 participants n=5 Participants
Number of diseased vessels Single	170 participants n=5 Participants
Number of diseased vessels Double	38 participants n=5 Participants
Number of diseased vessels Triple	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Intention-to-treat (ITT) definition: ITT subjects include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.

Outcome measures

Outcome measures
Measure	CTO Treatment n=211 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)	39 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Per-protocol (PP) definition: The per-protocol population is defined as all ITT subjects in whom at least 1 study stent was implanted, met procedure success, had available follow up data (i.e. a MACE event within 360 days or follow up of at least 330 days), and did not have major protocol deviations due to inappropriate enrollment.

Outcome measures

Outcome measures
Measure	CTO Treatment n=183 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)	15 Participants

PRIMARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.

Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on ARC MI (component 2)

Outcome measures

Outcome measures
Measure	CTO Treatment n=138 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) Guide Wire-related Endpoint	79.0 percentage of participants Interval 71.2 to 85.5
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) Component 1	89.9 percentage of participants Interval 83.6 to 94.3
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI) Component 2	89.1 percentage of participants Interval 82.7 to 93.8

PRIMARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on protocol MI (component 2)

Outcome measures

Outcome measures
Measure	CTO Treatment n=138 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI) Component 2	97.8 percentage of participants Interval 93.8 to 99.5
Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI) Guide Wire-related Endpoint	87.7 percentage of participants Interval 81.0 to 92.7
Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI) Component 1	89.9 percentage of participants Interval 83.6 to 94.3

PRIMARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: Angiographically Evaluable Subjects

1. Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and; 2. Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and; 3. Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and; 4. Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure

Outcome measures

Outcome measures
Measure	CTO Treatment n=65 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO	93.8 percentage of participants Interval 85.0 to 98.3

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Minimum Lumen Diameter (MLD): Pre-procedure	0.01 mm Standard Deviation 0.05

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=221 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Minimum Lumen Diameter (MLD): Post-procedure In-Segment	1.85 mm Standard Deviation 0.47
Minimum Lumen Diameter (MLD): Post-procedure In-Stent	2.32 mm Standard Deviation 0.39

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. TIMI Classification: TIMI 0 No perfusion. TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run. TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel. TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure 3	0.5 percentage of participants Interval 0.0 to 2.5
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure 0	95.9 percentage of participants Interval 92.4 to 98.1
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure 1	3.6 percentage of participants Interval 1.6 to 7.0
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure 2	0.0 percentage of participants Interval 0.0 to 1.6

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=221 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure 2	1.8 percentage of participants Interval 0.5 to 4.6
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure 3	97.7 percentage of participants Interval 94.8 to 99.3
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure 0	0.5 percentage of participants Interval 0.0 to 2.5
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure 1	0.0 percentage of participants Interval 0.0 to 1.7

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Achievement of \<50% diameter stenosis within the target lesion segment using assigned study device

Outcome measures

Outcome measures
Measure	CTO Treatment n=221 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Device Success	100 percentage of participants Interval 98.3 to 100.0

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Device success and absence of in-hospital MACE. Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves). Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment.

Outcome measures

Outcome measures
Measure	CTO Treatment n=221 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedure Success Per Protocol MI definition	96.4 percentage of participants Interval 93.0 to 98.4
Percentage of Participants With Procedure Success Per ARC MI definition	89.6 percentage of participants Interval 84.8 to 93.3

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique.

Outcome measures

Outcome measures
Measure	CTO Treatment n=187 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Antegrade Crossing	97.9 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

Outcome measures

Outcome measures
Measure	CTO Treatment n=7 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique	100 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

Outcome measures

Outcome measures
Measure	CTO Treatment n=1 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Knuckle Wire	100.0 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

Outcome measures

Outcome measures
Measure	CTO Treatment n=12 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing	91.7 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

Outcome measures

Outcome measures
Measure	CTO Treatment n=1 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)	100 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

Outcome measures

Outcome measures
Measure	CTO Treatment n=9 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Reverse CART	77.8 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set.The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

Outcome measures

Outcome measures
Measure	CTO Treatment n=1 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Kissing Wire Technique	100 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique.

Outcome measures

Outcome measures
Measure	CTO Treatment n=1 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Sub Intimal Technique	100.0 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

Outcome measures

Outcome measures
Measure	CTO Treatment n=5 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Procedural Success With Multiple Crossing Techniques	80.0 percentage of participants

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Resource Utilization: Procedural Time	79.88 Minutes Standard Deviation 48.5

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Resource Utilization: Fluoroscopic Time	33.61 Minutes Standard Deviation 23.29

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT set.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Resource Utilization: Contrast Volume	259.00 mL Standard Deviation 136.74

SECONDARY outcome

Timeframe: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Population: ITT Set

Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Percentage of Participants With Clinically Significant Perforation Post Last Mini-Trek Balloon Angiography (n=67)	0.0 percentage of participants Interval 0.0 to 5.4
Percentage of Participants With Clinically Significant Perforation Final Angiography (n=221)	0 percentage of participants Interval 0.0 to 1.7
Percentage of Participants With Clinically Significant Perforation Site reported (n=222)	0.0 percentage of participants Interval 0.0 to 1.6

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

Outcome measures

Outcome measures
Measure	CTO Treatment n=219 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Major Adverse Cardiac Events (MACE)	8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

Outcome measures

Outcome measures
Measure	CTO Treatment n=215 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Major Adverse Cardiac Events (MACE)	13 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

Outcome measures

Outcome measures
Measure	CTO Treatment n=211 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Major Adverse Cardiac Events (MACE)	21 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days.

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

Outcome measures

Outcome measures
Measure	CTO Treatment n=205 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Major Adverse Cardiac Events (MACE)	32 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

Outcome measures

Outcome measures
Measure	CTO Treatment n=199 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Major Adverse Cardiac Events (MACE)	37 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

Outcome measures

Outcome measures
Measure	CTO Treatment n=196 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Major Adverse Cardiac Events (MACE)	44 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Outcome measures
Measure	CTO Treatment n=218 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Death	1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=214 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Death	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=210 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Death	4 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=202 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Death	11 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Outcome measures

Outcome measures
Measure	CTO Treatment n=195 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Death	16 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Outcome measures

Outcome measures
Measure	CTO Treatment n=191 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Death	20 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded

Outcome measures

Outcome measures
Measure	CTO Treatment n=218 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Cardiac Death	1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=212 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Cardiac Death	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=208 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Cardiac Death	2 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=196 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Cardiac Death	5 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=188 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Cardiac Death	8 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Outcome measures

Outcome measures
Measure	CTO Treatment n=181 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants Experiencing Cardiac Death	10 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave.

Outcome measures

Outcome measures
Measure	CTO Treatment n=219 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)	24 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=213 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)	26 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=209 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)	29 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=197 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)	31 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=188 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)	34 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Outcome measures

Outcome measures
Measure	CTO Treatment n=182 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)	37 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

Outcome measures

Outcome measures
Measure	CTO Treatment n=219 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel-related MI	23 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

Outcome measures

Outcome measures
Measure	CTO Treatment n=213 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel-related MI	24 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

Outcome measures

Outcome measures
Measure	CTO Treatment n=209 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel-related MI	25 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

Outcome measures

Outcome measures
Measure	CTO Treatment n=197 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel-related MI	27 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

Outcome measures

Outcome measures
Measure	CTO Treatment n=188 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel-related MI	28 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

Outcome measures

Outcome measures
Measure	CTO Treatment n=181 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel-related MI	28 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.

Outcome measures

Outcome measures
Measure	CTO Treatment n=218 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Revascularization (TLR)	2 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Repeat PCI or CABG to the target lesion/site.

Outcome measures

Outcome measures
Measure	CTO Treatment n=212 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Revascularization (TLR)	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Repeat PCI or CABG to the target lesion/site.

Outcome measures

Outcome measures
Measure	CTO Treatment n=207 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Revascularization (TLR)	13 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Repeat PCI or CABG to the target lesion/site.

Outcome measures

Outcome measures
Measure	CTO Treatment n=194 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Revascularization (TLR)	18 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Repeat PCI or CABG to the target lesion/site.

Outcome measures

Outcome measures
Measure	CTO Treatment n=185 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Revascularization (TLR)	19 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Repeat PCI or CABG to the target lesion/site.

Outcome measures

Outcome measures
Measure	CTO Treatment n=177 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Revascularization (TLR)	21 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.

Outcome measures

Outcome measures
Measure	CTO Treatment n=218 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)	2 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=212 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=207 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)	13 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=194 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)	18 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=185 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)	19 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=177 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)	20 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study

Outcome measures

Outcome measures
Measure	CTO Treatment n=218 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With All Target Vessel Revascularization (TVR)	2 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=212 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With All Target Vessel Revascularization (TVR)	6 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=207 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With All Target Vessel Revascularization (TVR)	15 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=194 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With All Target Vessel Revascularization (TVR)	21 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=185 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With All Target Vessel Revascularization (TVR)	22 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=177 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With All Target Vessel Revascularization (TVR)	24 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when any of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.

Outcome measures

Outcome measures
Measure	CTO Treatment n=219 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel Failure (TVF)	8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.

Outcome measures

Outcome measures
Measure	CTO Treatment n=213 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel Failure (TVF)	12 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.

Outcome measures

Outcome measures
Measure	CTO Treatment n=209 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel Failure (TVF)	21 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.

Outcome measures

Outcome measures
Measure	CTO Treatment n=199 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel Failure (TVF)	29 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.

Outcome measures

Outcome measures
Measure	CTO Treatment n=192 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel Failure (TVF)	32 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.

Outcome measures

Outcome measures
Measure	CTO Treatment n=186 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Vessel Failure (TVF)	36 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

Outcome measures

Outcome measures
Measure	CTO Treatment n=219 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Failure (TLF)	8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

Outcome measures

Outcome measures
Measure	CTO Treatment n=213 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Failure (TLF)	11 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

Outcome measures

Outcome measures
Measure	CTO Treatment n=209 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Failure (TLF)	19 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

Outcome measures

Outcome measures
Measure	CTO Treatment n=199 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Failure (TLF)	26 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

Outcome measures

Outcome measures
Measure	CTO Treatment n=192 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Failure (TLF)	29 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

Outcome measures

Outcome measures
Measure	CTO Treatment n=186 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Target Lesion Failure (TLF)	32 Participants

SECONDARY outcome

Timeframe: Acute (0-24 hours)

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Academic Research Consortium (ARC) criteria; definite and probable Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent Thrombosis	0 Participants

SECONDARY outcome

Timeframe: Subacute (>24 hours to 30 days)

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Outcome measures

Outcome measures
Measure	CTO Treatment n=218 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent Thrombosis	2 Participants

SECONDARY outcome

Timeframe: Late (>30 days to 1 year)

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=206 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent Thrombosis	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Outcome measures

Outcome measures
Measure	CTO Treatment n=207 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent Thrombosis	3 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Academic Research Consortium (ARC) criteria. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

Outcome measures

Outcome measures
Measure	CTO Treatment n=192 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent Thrombosis	3 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=182 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent Thrombosis	3 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Outcome measures

Outcome measures
Measure	CTO Treatment n=174 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Stent Thrombosis	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 360 days or ITT subjects with follow-up of at least 330 days

Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Occurrence of Stent Fracture at Target Lesion	0.0 Participants

SECONDARY outcome

Timeframe: 2 years

Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Occurrence of Stent Fracture at Target Lesion	0.0 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Occurrence of Stent Fracture at Target Lesion	0.0 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame. The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

Outcome measures

Outcome measures
Measure	CTO Treatment n=222 Participants Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Number of Participants With Occurrence of Stent Fracture at Target Lesion	0.0 Participants

Adverse Events

CTO Treatment

Serious events: 92 serious events

Other events: 141 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	CTO Treatment n=222 participants at risk Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Blood and lymphatic system disorders Anaemia	1.4% 3/222 • 4 years ITT set
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.45% 1/222 • 4 years ITT set
Cardiac disorders Acute myocardial infarction	3.2% 7/222 • 4 years ITT set
Cardiac disorders Angina pectoris	9.0% 20/222 • 4 years ITT set
Cardiac disorders Angina unstable	2.3% 5/222 • 4 years ITT set
Cardiac disorders Atrial fibrillation	1.8% 4/222 • 4 years ITT set
Cardiac disorders Atrial flutter	0.45% 1/222 • 4 years ITT set
Cardiac disorders Atrioventricular block second degree	0.45% 1/222 • 4 years ITT set
Cardiac disorders Bradycardia	0.45% 1/222 • 4 years ITT set
Cardiac disorders Cardiac arrest	1.4% 3/222 • 4 years ITT set
Cardiac disorders Cardiac failure congestive	1.4% 3/222 • 4 years ITT set
Cardiac disorders Cardiogenic shock	0.45% 1/222 • 4 years ITT set
Cardiac disorders Coronary artery disease	2.7% 6/222 • 4 years ITT set
Cardiac disorders Coronary artery dissection	2.7% 6/222 • 4 years ITT set
Cardiac disorders Coronary artery occlusion	0.45% 1/222 • 4 years ITT set
Cardiac disorders Coronary artery stenosis	0.90% 2/222 • 4 years ITT set
Cardiac disorders Coronary artery thrombosis	0.45% 1/222 • 4 years ITT set
Cardiac disorders Myocardial infarction	2.3% 5/222 • 4 years ITT set
Cardiac disorders Myocardial ischaemia	1.4% 3/222 • 4 years ITT set
Cardiac disorders Pericardial effusion	0.45% 1/222 • 4 years ITT set
Cardiac disorders Pulseless electrical activity	0.45% 1/222 • 4 years ITT set
Cardiac disorders Supraventricular extrasystoles	0.45% 1/222 • 4 years ITT set
Cardiac disorders Supraventricular tachycardia	0.45% 1/222 • 4 years ITT set
Cardiac disorders Ventricular extrasystoles	0.45% 1/222 • 4 years ITT set
Cardiac disorders Ventricular fibrillation	0.90% 2/222 • 4 years ITT set
Cardiac disorders Ventricular tachycardia	1.8% 4/222 • 4 years ITT set
Eye disorders Cataract	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Abdominal pain	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Diverticular perforation	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Gastrointestinal haemorrhage	0.90% 2/222 • 4 years ITT set
Gastrointestinal disorders Haematemesis	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Haematochezia	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.45% 1/222 • 4 years ITT set
General disorders Catheter site haematoma	0.45% 1/222 • 4 years ITT set
General disorders Catheter site pain	0.45% 1/222 • 4 years ITT set
General disorders Chest pain	0.45% 1/222 • 4 years ITT set
General disorders Death	1.8% 4/222 • 4 years ITT set
General disorders Device malfunction	0.45% 1/222 • 4 years ITT set
General disorders Fatigue	0.45% 1/222 • 4 years ITT set
General disorders Medical device complication	0.45% 1/222 • 4 years ITT set
General disorders Non-cardiac chest pain	1.8% 4/222 • 4 years ITT set
General disorders Thrombosis in device	0.45% 1/222 • 4 years ITT set
Hepatobiliary disorders Cholelithiasis	0.45% 1/222 • 4 years ITT set
Infections and infestations Appendicitis	0.45% 1/222 • 4 years ITT set
Infections and infestations Arthritis bacterial	0.45% 1/222 • 4 years ITT set
Infections and infestations Chest wall abscess	0.45% 1/222 • 4 years ITT set
Infections and infestations Pneumonia	0.90% 2/222 • 4 years ITT set
Infections and infestations Sepsis	0.90% 2/222 • 4 years ITT set
Infections and infestations Septic shock	0.90% 2/222 • 4 years ITT set
Injury, poisoning and procedural complications Cardiac procedure complication	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Coronary artery restenosis	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Femur fracture	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications In-stent coronary artery restenosis	1.4% 3/222 • 4 years ITT set
Injury, poisoning and procedural complications Ureteric anastomosis complication	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.45% 1/222 • 4 years ITT set
Investigations Cardiac enzymes increased	0.45% 1/222 • 4 years ITT set
Metabolism and nutrition disorders Dehydration	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Osteoarthritis	0.90% 2/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.90% 2/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.45% 1/222 • 4 years ITT set
Nervous system disorders Cerebrovascular accident	1.4% 3/222 • 4 years ITT set
Nervous system disorders Haemorrhage intracranial	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Nephrolithiasis	0.45% 1/222 • 4 years ITT set
Nervous system disorders Presyncope	0.45% 1/222 • 4 years ITT set
Nervous system disorders Syncope	0.90% 2/222 • 4 years ITT set
Renal and urinary disorders Nephropathy	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Renal artery stenosis	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Renal failure acute	1.4% 3/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 4/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.45% 1/222 • 4 years ITT set
Skin and subcutaneous tissue disorders Rash	0.45% 1/222 • 4 years ITT set
Vascular disorders Aortic aneurysm	0.90% 2/222 • 4 years ITT set
Vascular disorders Aortic dissection	0.90% 2/222 • 4 years ITT set
Vascular disorders Deep vein thrombosis	0.45% 1/222 • 4 years ITT set
Vascular disorders Hypotension	0.90% 2/222 • 4 years ITT set
Vascular disorders Intermittent claudication	0.90% 2/222 • 4 years ITT set
Vascular disorders Ischaemia	0.45% 1/222 • 4 years ITT set
Vascular disorders Orthostatic hypotension	0.45% 1/222 • 4 years ITT set
Vascular disorders Peripheral arterial occlusive disease	0.90% 2/222 • 4 years ITT set
Vascular disorders Peripheral vascular disorder	0.90% 2/222 • 4 years ITT set
Cardiac disorders Cardiac failure chronic	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Melaena	0.45% 1/222 • 4 years ITT set
Infections and infestations Cellulitis	0.45% 1/222 • 4 years ITT set
Infections and infestations Upper respiratory tract infection	0.45% 1/222 • 4 years ITT set
Infections and infestations Urinary tract infection bacterial	0.45% 1/222 • 4 years ITT set
Infections and infestations Urinary tract infection	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Laceration	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Pain in extremity	0.45% 1/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.45% 1/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.45% 1/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Urinary retention	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.45% 1/222 • 4 years ITT set
Vascular disorders Arteriosclerosis	0.45% 1/222 • 4 years ITT set

Other adverse events

Other adverse events
Measure	CTO Treatment n=222 participants at risk Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Blood and lymphatic system disorders Anaemia	3.6% 8/222 • 4 years ITT set
Blood and lymphatic system disorders Iron deficiency anaemia	0.45% 1/222 • 4 years ITT set
Blood and lymphatic system disorders Leukocytosis	0.45% 1/222 • 4 years ITT set
Blood and lymphatic system disorders Lymphadenopathy	0.45% 1/222 • 4 years ITT set
Blood and lymphatic system disorders Neutropenia	0.45% 1/222 • 4 years ITT set
Blood and lymphatic system disorders Thrombocytopenia	0.45% 1/222 • 4 years ITT set
Cardiac disorders Acute myocardial infarction	3.6% 8/222 • 4 years ITT set
Cardiac disorders Angina pectoris	14.4% 32/222 • 4 years ITT set
Cardiac disorders Arteriospasm coronary	0.45% 1/222 • 4 years ITT set
Cardiac disorders Atrial fibrillation	3.2% 7/222 • 4 years ITT set
Cardiac disorders Atrial flutter	0.45% 1/222 • 4 years ITT set
Cardiac disorders Atrial tachycardia	0.45% 1/222 • 4 years ITT set
Cardiac disorders Atrioventricular block first degree	0.45% 1/222 • 4 years ITT set
Cardiac disorders Bradycardia	2.3% 5/222 • 4 years ITT set
Cardiac disorders Coronary artery dissection	8.1% 18/222 • 4 years ITT set
Cardiac disorders Coronary artery perforation	0.45% 1/222 • 4 years ITT set
Cardiac disorders Left ventricular dysfunction	0.45% 1/222 • 4 years ITT set
Cardiac disorders Myocardial ischaemia	1.8% 4/222 • 4 years ITT set
Cardiac disorders Pericardial effusion	0.90% 2/222 • 4 years ITT set
Cardiac disorders Supraventricular tachycardia	1.4% 3/222 • 4 years ITT set
Cardiac disorders Tachycardia	0.45% 1/222 • 4 years ITT set
Cardiac disorders Ventricular extrasystoles	1.4% 3/222 • 4 years ITT set
Cardiac disorders Ventricular tachycardia	3.2% 7/222 • 4 years ITT set
Endocrine disorders Cushing's syndrome	0.45% 1/222 • 4 years ITT set
Eye disorders Ocular hyperaemia	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Abdominal discomfort	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Abdominal distension	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Abdominal pain	2.3% 5/222 • 4 years ITT set
Gastrointestinal disorders Constipation	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Diarrhoea	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Dyspepsia	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Gastrooesophageal reflux disease	0.90% 2/222 • 4 years ITT set
Gastrointestinal disorders Haematochezia	0.90% 2/222 • 4 years ITT set
Gastrointestinal disorders Mesenteric artery stenosis	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Mouth ulceration	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Nausea	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Retroperitoneal haematoma	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Retroperitoneal haemorrhage	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Swollen tongue	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Umbilical hernia	0.45% 1/222 • 4 years ITT set
General disorders Catheter site haematoma	5.9% 13/222 • 4 years ITT set
General disorders Catheter site haemorrhage	0.45% 1/222 • 4 years ITT set
General disorders Catheter site pain	3.2% 7/222 • 4 years ITT set
General disorders Catheter site related reaction	0.45% 1/222 • 4 years ITT set
General disorders Chest pain	0.90% 2/222 • 4 years ITT set
General disorders Fatigue	1.8% 4/222 • 4 years ITT set
General disorders Gait disturbance	0.45% 1/222 • 4 years ITT set
General disorders Influenza like illness	0.45% 1/222 • 4 years ITT set
General disorders Injection site haemorrhage	0.45% 1/222 • 4 years ITT set
General disorders Non-cardiac chest pain	5.9% 13/222 • 4 years ITT set
General disorders Oedema peripheral	0.45% 1/222 • 4 years ITT set
General disorders Pyrexia	0.45% 1/222 • 4 years ITT set
General disorders Thrombosis in device	0.90% 2/222 • 4 years ITT set
Hepatobiliary disorders Bile duct stenosis	0.45% 1/222 • 4 years ITT set
Immune system disorders Drug hypersensitivity	0.90% 2/222 • 4 years ITT set
Infections and infestations Acute sinusitis	0.45% 1/222 • 4 years ITT set
Infections and infestations Bronchitis	0.45% 1/222 • 4 years ITT set
Infections and infestations Device related infection	0.45% 1/222 • 4 years ITT set
Infections and infestations Folliculitis	0.45% 1/222 • 4 years ITT set
Infections and infestations Infected cyst	0.45% 1/222 • 4 years ITT set
Infections and infestations Pneumonia	1.4% 3/222 • 4 years ITT set
Infections and infestations Sepsis	1.4% 3/222 • 4 years ITT set
Infections and infestations Urinary tract infection	1.8% 4/222 • 4 years ITT set
Infections and infestations Wound infection	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Cardiac procedure complication	2.3% 5/222 • 4 years ITT set
Injury, poisoning and procedural complications Meniscus lesion	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Vascular graft occlusion	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.90% 2/222 • 4 years ITT set
Investigations Blood creatine phosphokinase MB increased	0.90% 2/222 • 4 years ITT set
Investigations Cardiac enzymes increased	2.3% 5/222 • 4 years ITT set
Investigations Cardiac stress test abnormal	0.45% 1/222 • 4 years ITT set
Investigations Electrocardiogram QRS complex abnormal	0.45% 1/222 • 4 years ITT set
Investigations Oxygen consumption decreased	0.45% 1/222 • 4 years ITT set
Investigations Smear cervix abnormal	0.45% 1/222 • 4 years ITT set
Investigations Transaminases increased	0.45% 1/222 • 4 years ITT set
Metabolism and nutrition disorders Hyperglycaemia	0.45% 1/222 • 4 years ITT set
Metabolism and nutrition disorders Hypoglycaemia	0.45% 1/222 • 4 years ITT set
Metabolism and nutrition disorders Hypokalaemia	1.8% 4/222 • 4 years ITT set
Metabolism and nutrition disorders Lactic acidosis	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 3/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Back pain	2.7% 6/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Enthesopathy	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Muscle spasms	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Neck pain	0.45% 1/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Osteoarthritis	0.90% 2/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Pain in extremity	1.8% 4/222 • 4 years ITT set
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.45% 1/222 • 4 years ITT set
Nervous system disorders Dizziness	1.4% 3/222 • 4 years ITT set
Nervous system disorders Headache	0.45% 1/222 • 4 years ITT set
Nervous system disorders Hypoaesthesia	0.45% 1/222 • 4 years ITT set
Nervous system disorders Paraesthesia	0.45% 1/222 • 4 years ITT set
Nervous system disorders Presyncope	0.90% 2/222 • 4 years ITT set
Nervous system disorders Syncope	1.4% 3/222 • 4 years ITT set
Psychiatric disorders Anxiety	0.45% 1/222 • 4 years ITT set
Psychiatric disorders Confusional state	0.45% 1/222 • 4 years ITT set
Psychiatric disorders Depression	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Haematuria	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Renal failure acute	2.3% 5/222 • 4 years ITT set
Renal and urinary disorders Renal failure	0.45% 1/222 • 4 years ITT set
Reproductive system and breast disorders Erectile dysfunction	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Cough	1.4% 3/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.90% 2/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 11/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Epistaxis	0.90% 2/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.90% 2/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.90% 2/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.90% 2/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.90% 2/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Throat irritation	0.45% 1/222 • 4 years ITT set
Skin and subcutaneous tissue disorders Decubitus ulcer	0.45% 1/222 • 4 years ITT set
Skin and subcutaneous tissue disorders Ecchymosis	0.90% 2/222 • 4 years ITT set
Skin and subcutaneous tissue disorders Skin lesion	0.45% 1/222 • 4 years ITT set
Vascular disorders Arteriovenous fistula	0.45% 1/222 • 4 years ITT set
Vascular disorders Deep vein thrombosis	0.90% 2/222 • 4 years ITT set
Vascular disorders Flushing	0.45% 1/222 • 4 years ITT set
Vascular disorders Haematoma	0.45% 1/222 • 4 years ITT set
Vascular disorders Haemorrhage	0.90% 2/222 • 4 years ITT set
Vascular disorders Hypertension	1.8% 4/222 • 4 years ITT set
Vascular disorders Hypotension	4.5% 10/222 • 4 years ITT set
Vascular disorders Intermittent claudication	2.3% 5/222 • 4 years ITT set
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.45% 1/222 • 4 years ITT set
Cardiac disorders Angina unstable	2.3% 5/222 • 4 years ITT set
Cardiac disorders Atrioventricular block second degree	0.45% 1/222 • 4 years ITT set
Cardiac disorders Cardiac arrest	1.4% 3/222 • 4 years ITT set
Cardiac disorders Cardiac failure chronic	0.45% 1/222 • 4 years ITT set
Cardiac disorders Cardiac failure congestive	1.4% 3/222 • 4 years ITT set
Cardiac disorders Cardiogenic shock	0.45% 1/222 • 4 years ITT set
Cardiac disorders Coronary artery disease	2.7% 6/222 • 4 years ITT set
Cardiac disorders Coronary artery occlusion	0.45% 1/222 • 4 years ITT set
Cardiac disorders Coronary artery stenosis	0.90% 2/222 • 4 years ITT set
Cardiac disorders Coronary artery thrombosis	0.45% 1/222 • 4 years ITT set
Cardiac disorders Myocardial infarction	2.3% 5/222 • 4 years ITT set
Cardiac disorders Pulseless electrical activity	0.45% 1/222 • 4 years ITT set
Cardiac disorders Supraventricular extrasystoles	0.45% 1/222 • 4 years ITT set
Cardiac disorders Ventricular fibrillation	0.90% 2/222 • 4 years ITT set
Eye disorders Cataract	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Diverticular perforation	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Gastrointestinal haemorrhage	0.90% 2/222 • 4 years ITT set
Gastrointestinal disorders Haematemesis	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.45% 1/222 • 4 years ITT set
Gastrointestinal disorders Melaena	0.45% 1/222 • 4 years ITT set
General disorders Device malfunction	0.45% 1/222 • 4 years ITT set
General disorders Medical device complication	0.45% 1/222 • 4 years ITT set
Hepatobiliary disorders Cholelithiasis	0.45% 1/222 • 4 years ITT set
Infections and infestations Appendicitis	0.45% 1/222 • 4 years ITT set
Infections and infestations Arthritis bacterial	0.45% 1/222 • 4 years ITT set
Infections and infestations Cellulitis	0.45% 1/222 • 4 years ITT set
Infections and infestations Chest wall abscess	0.45% 1/222 • 4 years ITT set
Infections and infestations Septic shock	0.90% 2/222 • 4 years ITT set
Infections and infestations Upper respiratory tract infection	0.45% 1/222 • 4 years ITT set
Infections and infestations Urinary tract infection bacterial	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Coronary artery restenosis	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Femur fracture	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications In-stent coronary artery restenosis	1.4% 3/222 • 4 years ITT set
Injury, poisoning and procedural complications Laceration	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Muscle strain	0.45% 1/222 • 4 years ITT set
Injury, poisoning and procedural complications Ureteric anastomosis complication	0.45% 1/222 • 4 years ITT set
Metabolism and nutrition disorders Dehydration	0.45% 1/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.45% 1/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.45% 1/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.90% 2/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.45% 1/222 • 4 years ITT set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.45% 1/222 • 4 years ITT set
Nervous system disorders Cerebrovascular accident	1.4% 3/222 • 4 years ITT set
Nervous system disorders Haemorrhage intracranial	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Nephrolithiasis	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Nephropathy	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Renal artery stenosis	0.45% 1/222 • 4 years ITT set
Renal and urinary disorders Urinary retention	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.45% 1/222 • 4 years ITT set
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.45% 1/222 • 4 years ITT set
Vascular disorders Aortic aneurysm	0.90% 2/222 • 4 years ITT set
Vascular disorders Aortic dissection	0.90% 2/222 • 4 years ITT set
Vascular disorders Arteriosclerosis	0.45% 1/222 • 4 years ITT set
Vascular disorders Ischaemia	0.45% 1/222 • 4 years ITT set
Vascular disorders Orthostatic hypotension	0.45% 1/222 • 4 years ITT set
Vascular disorders Peripheral arterial occlusive disease	0.90% 2/222 • 4 years ITT set
Vascular disorders Peripheral vascular disorder	0.90% 2/222 • 4 years ITT set
Skin and subcutaneous tissue disorders Rash	0.45% 1/222 • 4 years ITT set

Additional Information

Jennifer M Jones-McMeans, PhD (Associate Director Clinical Research)

Abbott Vascular

Phone: 408-845-1459

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60