Trial Outcomes & Findings for SPIRIT PRIME Clinical Trial (NCT NCT00916370)

Last Updated: 2015-06-08

Results Overview

The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

525 participants

Primary outcome timeframe

1 year

Results posted on

2015-06-08

Participant Flow

Subjects enrolled into this trial will be male and female subjects from the general interventional cardiology population. The study commenced on June 5, 2009 with the first subject enrolled on June 15, 2009. The last subject in the CSR was enrolled February 12, 2010, and the last subject enrolled in LLR was on April 6, 2010.

Intention-to-treat (ITT) set includes 525 subjects: 415 in core size registry (CSR) arm and 110 in long lesion registry (LLR) arm. Full analysis set (FAS) (n=505, 401 in CSR arm and 104 in LLR arm) includes subjects who have received at least 1 of the following: the core size XIENCE PRIME or XIENCE PRIME LL stent system, including bailout.

Participant milestones

Participant milestones
Measure	Core Size Registry Core size indicates the range of diameters of the stents used.	Long Lesion Registry Use of long lesion stents.
Overall Study STARTED	401	104
Overall Study COMPLETED	396	102
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Core Size Registry Core size indicates the range of diameters of the stents used.	Long Lesion Registry Use of long lesion stents.
Overall Study Death	3	1
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	0	1

Baseline Characteristics

SPIRIT PRIME Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.	Total n=505 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	234 Participants n=5 Participants	56 Participants n=7 Participants	290 Participants n=5 Participants
Age, Categorical >=65 years	167 Participants n=5 Participants	48 Participants n=7 Participants	215 Participants n=5 Participants
Age, Continuous	62.70 years STANDARD_DEVIATION 10.23 • n=5 Participants	63.46 years STANDARD_DEVIATION 9.44 • n=7 Participants	62.86 years STANDARD_DEVIATION 10.07 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	39 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	282 Participants n=5 Participants	65 Participants n=7 Participants	347 Participants n=5 Participants
Region of Enrollment United States	376 participants n=5 Participants	96 participants n=7 Participants	472 participants n=5 Participants
Region of Enrollment Australia	25 participants n=5 Participants	8 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Lesion Failure (TLF)	4.5 percentage of participants	7.7 percentage of participants

PRIMARY outcome

Timeframe: 2 years

The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Lesion Failure (TLF)	6.4 percentage of participants	9.6 percentage of participants

PRIMARY outcome

Timeframe: 3 years

The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Lesion Failure (TLF)	8.5 percentage of participants	9.6 percentage of participants

SECONDARY outcome

Timeframe: From insertion to withdrawal of guide catheter

Population: The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.

Procedure time is defined as time between insertion and withdrawal of guide catheter.

Outcome measures

Outcome measures
Measure	Core Size Registry n=403 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=106 Participants Use of long lesion stents.
Procedure Time	32.6 Minutes Standard Deviation 21.1	46.9 Minutes Standard Deviation 30.9

SECONDARY outcome

Timeframe: From the start of index procedure to end of index procedure

Device success is defined as achievement of a final in-stent residual diameter stenosis of \< 50% (by QCA).

Outcome measures

Outcome measures
Measure	Core Size Registry n=449 Lesions Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=125 Lesions Use of long lesion stents.
Device Success (Lesion Basis)	98.2 percentage of lesions	97.6 percentage of lesions

SECONDARY outcome

Timeframe: From the start of index procedure to end of index procedure

Population: The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Out of these subjects, 2 in the CSR and 1 in the LLR did not have QCA data and therefore were excluded. So, the final analysis contained 401 ITT CSR subjects and 105 ITT LLR subjects.

Procedure success is defined as achievement of a final in-stent diameter stenosis of \< 50% (by QCA). Per Protocol.

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=105 Participants Use of long lesion stents.
Procedural Success (Subject Basis)	97.8 percentage of participants	94.3 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is less than or equal to 7 days post index procedure

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death (Cardiac, Vascular, Non-cardiovascular)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death (Cardiac, Vascular, Non-cardiovascular)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death (Cardiac, Vascular, Non-cardiovascular)	0.5 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death (Cardiac, Vascular, Non-cardiovascular)	0.8 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death (Cardiac, Vascular, Non-cardiovascular)	2.0 percentage of participants	2.9 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death (Cardiac, Vascular, Non-cardiovascular)	3.1 percentage of participants	2.9 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	1.7 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	1.7 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	1.8 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	1.8 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	1.8 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	2.6 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Non-target Vessel MI (Q-wave, Non Q-wave)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Non-target Vessel MI (Q-wave, Non Q-wave)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Non-target Vessel MI (Q-wave, Non Q-wave)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Non-target Vessel MI (Q-wave, Non Q-wave)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Non-target Vessel MI (Q-wave, Non Q-wave)	0.3 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Non-target Vessel MI (Q-wave, Non Q-wave)	0.8 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated-Target Lesion Revascularization	0.2 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated-Target Lesion Revascularization	0.5 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated-Target Lesion Revascularization	1.8 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated-Target Lesion Revascularization	2.5 percentage of participants	2.9 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated-Target Lesion Revascularization	4.1 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated-Target Lesion Revascularization	5.4 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)	0.5 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)	1.2 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)	3.3 percentage of participants	3.8 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)	4.5 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)	6.9 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)	9.5 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TLR (CI and Non-CI)	0.2 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TLR (CI and Non-CI)	0.5 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TLR (CI and Non-CI)	2.0 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TLR (CI and Non-CI)	2.8 percentage of participants	2.9 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TLR (CI and Non-CI)	4.3 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TLR (CI and Non-CI)	5.6 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TVR (CI and Non-CI)	0.5 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TVR (CI and Non-CI)	1.2 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TVR (CI and Non-CI)	3.5 percentage of participants	3.8 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TVR (CI and Non-CI)	4.8 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TVR (CI and Non-CI)	7.1 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All TVR (CI and Non-CI)	10 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Coronary Revascularization (TVR and Non-TVR)	0.5 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Coronary Revascularization (TVR and Non-TVR)	1.5 percentage of participants	3.8 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Coronary Revascularization (TVR and Non-TVR)	4.8 percentage of participants	6.7 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Coronary Revascularization (TVR and Non-TVR)	6.8 percentage of participants	8.7 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Coronary Revascularization (TVR and Non-TVR)	10.5 percentage of participants	13.5 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Coronary Revascularization (TVR and Non-TVR)	14.9 percentage of participants	14.4 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/All MI	1.7 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/ All MI	1.7 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/All MI	2.0 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/All MI	2.0 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/All MI	2.6 percentage of participants	5.8 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/All MI	3.8 percentage of participants	5.8 percentage of participants

SECONDARY outcome

Timeframe: in-hospital

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/ All MI/CI-TLR	2.0 percentage of participants	5.8 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/ All MI/CI-TLR	2.2 percentage of participants	5.8 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/ All MI/CI-TLR	3.8 percentage of participants	6.7 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/ All MI/CI-TLR	4.5 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/ All MI/CI-TLR	6.6 percentage of participants	10.6 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Cardiac Death/ All MI/CI-TLR	9.0 percentage of participants	10.6 percentage of participants

SECONDARY outcome

Timeframe: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death/All MI/All Coronary Revascularization	2.2 percentage of participants	5.8 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death/All MI/All Coronary Revascularization	3.2 percentage of participants	8.7 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death/All MI/All Coronary Revascularization	7.0 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death/All MI/All Coronary Revascularization	9.0 percentage of participants	14.4 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=392 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death/All MI/All Coronary Revascularization	13.8 percentage of participants	20.2 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Per Protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=390 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
All Death/All MI/All Coronary Revascularization	19 percentage of participants	20.2 percentage of participants

SECONDARY outcome

Timeframe: Acute (≤1 day)

Per protocol and per Academic Research Consortium (ARC, definite/probable)

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Stent Thrombosis Per ARC	0.5 percentage of participants	0.0 percentage of participants
Stent Thrombosis Per Protocol	0.5 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Subacute (>1 - 30 days)

Per protocol and per ARC

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Stent Thrombosis Per ARC	0.0 percentage of participants	0.0 percentage of participants
Stent Thrombosis Per Protocol	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Acute/Subacute (0 - 30 days)

Per protocol and per ARC

Outcome measures

Outcome measures
Measure	Core Size Registry n=401 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Stent Thrombosis Per ARC	0.5 percentage of participants	0.0 percentage of participants
Stent Thrombosis Per Protocol	0.5 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Late (31 - 393 days)

Per protocol and per ARC

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Stent Thrombosis Per ARC	0.0 percentage of participants	0.0 percentage of participants
Stent Thrombosis Per Protocol	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Late (31 - 758 days)

Per protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=385 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=100 Participants Use of long lesion stents.
Stent Thrombosis	0.3 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Very Late (394 - 758 days)

Per ARC, definite and probable

Outcome measures

Outcome measures
Measure	Core Size Registry n=385 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=100 Participants Use of long lesion stents.
Stent Thrombosis	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Late (31 - 1123 days)

Per protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=378 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=99 Participants Use of long lesion stents.
Stent Thrombosis	0.5 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Very Late (394 - 1123 days)

Per ARC, definite and probable

Outcome measures

Outcome measures
Measure	Core Size Registry n=379 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=99 Participants Use of long lesion stents.
Stent Thrombosis	0.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Overall (0-393 days)

Per protocol and per ARC

Outcome measures

Outcome measures
Measure	Core Size Registry n=399 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=104 Participants Use of long lesion stents.
Stent Thrombosis Per ARC	0.5 percentage of participants	0.0 percentage of participants
Stent Thrombosis Per Protocol	0.5 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Overall (0-758 days)

Per protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=385 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=100 Participants Use of long lesion stents.
Stent Thrombosis	0.8 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Overall (0-758 days)

Per ARC, definite and probable

Outcome measures

Outcome measures
Measure	Core Size Registry n=386 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=100 Participants Use of long lesion stents.
Stent Thrombosis	0.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Overall (0 - 1123 days)

Per protocol

Outcome measures

Outcome measures
Measure	Core Size Registry n=378 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=99 Participants Use of long lesion stents.
Stent Thrombosis	1.1 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Overall (0 - 1123 days)

Per ARC, definite and probable

Outcome measures

Outcome measures
Measure	Core Size Registry n=380 Participants Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=99 Participants Use of long lesion stents.
Stent Thrombosis	0.8 percentage of participants	0 percentage of participants

Adverse Events

Core Size Registry

Serious events: 203 serious events

Other events: 222 other events

Deaths: 0 deaths

Long Lesion Registry

Serious events: 49 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Core Size Registry n=412 participants at risk Core size indicates the range of diameters of the stents used.	Long Lesion Registry n=110 participants at risk Use of long lesion stents.
General disorders Fatigue	6.1% 25/412 • Number of events 25 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	2.7% 3/110 • Number of events 3 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
General disorders Non-cardiac chest pain	17.2% 71/412 • Number of events 77 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	11.8% 13/110 • Number of events 14 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
Cardiac disorders Angina pectoris	21.6% 89/412 • Number of events 114 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	18.2% 20/110 • Number of events 24 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
Cardiac disorders Coronary artery dissection	2.7% 11/412 • Number of events 11 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	8.2% 9/110 • Number of events 9 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
General disorders Catheter site haematoma	5.1% 21/412 • Number of events 21 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	4.5% 5/110 • Number of events 5 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
Nervous system disorders Headache	6.6% 27/412 • Number of events 27 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	2.7% 3/110 • Number of events 6 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.3% 26/412 • Number of events 27 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	2.7% 3/110 • Number of events 3 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
Vascular disorders Hypertension	2.7% 11/412 • Number of events 12 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	5.5% 6/110 • Number of events 6 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
General disorders Catheter site haemorrhage	3.6% 15/412 • Number of events 16 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	5.5% 6/110 • Number of events 6 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint
Musculoskeletal and connective tissue disorders Back pain	5.8% 24/412 • Number of events 28 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint	6.4% 7/110 • Number of events 7 • 3 years These are site-reported, un-adjudicated adverse events regardless of relationship to the device in intention-to-treat population. The number of participants at risk excludes subjects who were early terminated up to 1123 days and had no events through the given timepoint

Additional Information

Robert Smith Jr, Ph.D., Sr Clinical Research Scientist

Abbott Vascular

Phone: 408-845-8265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication except to delay any proposed publication or presentation to enable the Sponsor to secure patent or other protection of proprietary rights.
Publication restrictions are in place

Restriction type: OTHER