Trial Outcomes & Findings for OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation (NCT NCT02471586)

Last Updated: 2021-04-01

Results Overview

Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows: 1. Non-inferiority: OCT vs. IVUS guided stenting Non-inferiority of OCT guided stenting to IVUS guided stenting will be analyzed for the mean difference between the post PCI MSA for the OCT and IVUS arms with non-inferiority margin of 1.0 mm\^2. 2. Superiority: OCT vs. Angiography guided stenting If the OCT guided stenting arm was found to be non-inferior to the IVUS guided stenting arm, the superiority of OCT to angiography will be tested for the mean difference between the post PCI MSA for the OCT and angiography arms. 3. Superiority: OCT vs. IVUS guided stenting If the OCT guided stenting arm was found to be superior to the IVUS guided stenting arm, then the superiority of OCT to IVUS will be tested for the mean difference between the post PCI MSA for the OCT and IVUS arms.

Recruitment status

COMPLETED

Study phase

Target enrollment

450 participants

Primary outcome timeframe

Post-procedure within 1 hour

Results posted on

2021-04-01

Participant Flow

A total of 1,759 subjects were initially consented, however only 450 subjects were actually randomized and enrolled into the trial across 29 sites. The first randomized subject was enrolled on May 13, 2015, and the last randomized subject was enrolled on April 5, 2016. Each site was allowed to enroll a maximum of 65 subjects in the trial. The subjects were followed through 12-months and the last subject follow-up visit was completed on April 25, 2017.

Of the 1759 subjects consented, 1309 subjects were not randomized due to failed screening (n=1230), roll-in subjects (n=74), withdrawal of consent (n=1), withdrawal by the investigator (n=3) and software malfunction (n=1).

Participant milestones

Participant milestones
Measure	Coronary PCI Guided by OCT Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Overall Study STARTED	158	146	146
Overall Study COMPLETED	153	136	142
Overall Study NOT COMPLETED	5	10	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Coronary PCI Guided by OCT Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Overall Study Lost to Follow-up	3	8	4
Overall Study Death	2	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type	Total n=450 Participants Total of all reporting groups
Age, Continuous	65.5 years STANDARD_DEVIATION 9.3 • n=158 Participants	65.8 years STANDARD_DEVIATION 9.5 • n=146 Participants	65.4 years STANDARD_DEVIATION 11.2 • n=146 Participants	65.6 years STANDARD_DEVIATION 10.0 • n=450 Participants
Sex: Female, Male Female	49 Participants n=158 Participants	39 Participants n=146 Participants	39 Participants n=146 Participants	127 Participants n=450 Participants
Sex: Female, Male Male	109 Participants n=158 Participants	107 Participants n=146 Participants	107 Participants n=146 Participants	323 Participants n=450 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	3 participants n=158 Participants	2 participants n=146 Participants	1 participants n=146 Participants	6 participants n=450 Participants
Region of Enrollment Belgium	1 participants n=158 Participants	2 participants n=146 Participants	1 participants n=146 Participants	4 participants n=450 Participants
Region of Enrollment United States	89 participants n=158 Participants	81 participants n=146 Participants	85 participants n=146 Participants	255 participants n=450 Participants
Region of Enrollment Japan	16 participants n=158 Participants	15 participants n=146 Participants	13 participants n=146 Participants	44 participants n=450 Participants
Region of Enrollment Italy	32 participants n=158 Participants	31 participants n=146 Participants	32 participants n=146 Participants	95 participants n=450 Participants
Region of Enrollment United Kingdom	4 participants n=158 Participants	4 participants n=146 Participants	3 participants n=146 Participants	11 participants n=450 Participants
Region of Enrollment Germany	4 participants n=158 Participants	3 participants n=146 Participants	3 participants n=146 Participants	10 participants n=450 Participants
Region of Enrollment Spain	9 participants n=158 Participants	8 participants n=146 Participants	8 participants n=146 Participants	25 participants n=450 Participants

PRIMARY outcome

Timeframe: Post-procedure within 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA)	5.79 mm^2 Interval 4.54 to 7.34	5.89 mm^2 Interval 4.67 to 7.8	5.49 mm^2 Interval 4.39 to 6.59

PRIMARY outcome

Timeframe: During procedure, an average of 1 hour

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, pericardiocentesis, thrombus aspiration and other).

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) Intra-Procedural Complications Required Active Interventions	4 Participants	1 Participants	1 Participants
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) Prolonged Balloon Inflations	0 Participants	0 Participants	0 Participants
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) Additional Stent implantation	4 Participants	1 Participants	1 Participants
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) Pericardiocentesis	0 Participants	0 Participants	0 Participants
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) Thrombus Aspiration	0 Participants	0 Participants	0 Participants
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) Other Interventions	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Acute procedural success are classified as: A) Optimal (%) The MSA of the proximal segment is ≥95% of the proximal reference lumen area and the MSA of the distal segment is ≥95% of the distal reference lumen area. B) Acceptable (%) The MSA of the proximal segment is ≥90% and \<95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and \<95% of the distal reference lumen area. C) Optimal and Acceptable (%) The MSA of the proximal segment is ≥90% and \<95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and \<95% of the distal reference lumen area. D) Unacceptable (%) The MSA of the proximal segment is \<90% of the proximal lumen area, and/or the MSA of the distal segment is \<90% of the distal reference lumen area.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Number of Participants With Acute Procedural Success Optimal (≥95%)	36 Participants	32 Participants	23 Participants
Number of Participants With Acute Procedural Success Acceptable (90 to 95%)	22 Participants	16 Participants	5 Participants
Number of Participants With Acute Procedural Success Unacceptable (<90%)	82 Participants	82 Participants	108 Participants

SECONDARY outcome

Timeframe: Up to 1 hour post-procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis.

Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Rate of Post-PCI Stent Expansion (%)	87.6 percentage of stent expansion Standard Deviation 16.6	86.5 percentage of stent expansion Standard Deviation 15.9	82.9 percentage of stent expansion Standard Deviation 12.9

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Mean stent expansion is defined as the mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Rate of Mean Stent Expansion (%)	105.8 percentage of mean stent expansion Interval 97.8 to 119.8	106.3 percentage of mean stent expansion Interval 96.7 to 116.6	101.4 percentage of mean stent expansion Interval 91.9 to 110.2

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Plaque protrusion and thrombus is defined as a mass attached to the luminal surface or floating within the lumen, meeting the following criteria: Protrusion is defined as any mass at least 0.2 mm beyond the luminal edge of a strut and will be further classified as Major and Minor. Major: Protrusion area/Stent area at site of tissue protrusion ≥10% Minor: Protrusion area/Stent area at site of tissue protrusion\<10%

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Number of Participants With Plaque Protrusion and Thrombus Major	27 Participants	27 Participants	25 Participants
Number of Participants With Plaque Protrusion and Thrombus Minor	67 Participants	73 Participants	70 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Untreated reference segment disease is defined as untreated Mean Lumen Area (MLA) ≤60% of the adjacent reference segment lumen area up to 10 mm from the proximal and distal stent edges.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Number of Participants With Untreated Reference Segment Disease	44 Participants	45 Participants	39 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Edge Dissections are classified as A) Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length B) Minor (%): any visible edge dissection \<60 degrees of the circumference of the vessel and \< 3 mm in length C) All (Major and Minor) Edge dissections will be further classified as: I. Intimal (limited to the intima layer, i.e. not extending beyond the internal elastic lamina) II. Medial (extending into the media layer) III. Adventitial (extending through the external elastic membrane

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Number of Participants With Edge Dissections Major	19 Participants	35 Participants	26 Participants
Number of Participants With Edge Dissections Minor	20 Participants	18 Participants	35 Participants
Number of Participants With Edge Dissections All (Major and Minor)	39 Participants	53 Participants	61 Participants
Number of Participants With Edge Dissections Intimal	16 Participants	11 Participants	21 Participants
Number of Participants With Edge Dissections Medial	27 Participants	45 Participants	40 Participants
Number of Participants With Edge Dissections Adventitial	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch). Malapposition will be further classified as: Major: if associated with unacceptable stent expansion Minor: if not associated with significant under-expansion

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Number of Participants With Stent Malapposition Major	15 Participants	28 Participants	44 Participants
Number of Participants With Stent Malapposition Minor	43 Participants	24 Participants	39 Participants
Number of Participants With Stent Malapposition All (Major and Minor)	58 Participants	52 Participants	83 Participants

SECONDARY outcome

Timeframe: Pre-PCI OCT Run procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The visibility of the vessel external elastic lamina (EEL) border by OCT will be evaluated at both reference sites (proximal and distal) and the MSA before AND after intervention and then classified into 3 grades: A) Good: ≥75% (270°) of visible circumference B) Moderate: ≥50% (180°) - \<75% (270°) of visible circumference C) Poor: \<50% (180°) of visible circumference

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=144 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Number of Participants With Border Detection (OCT Arm Only) Poor <180º of Visible EEL Circumference	7 Participants	0 Participants	0 Participants
Number of Participants With Border Detection (OCT Arm Only) Moderate >=1800, <2700 of Visible EEL Circumference	28 Participants	0 Participants	0 Participants
Number of Participants With Border Detection (OCT Arm Only) Good >=2700 of Visible EEL Circumference	109 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Clinical decision making will be assessed on the basis of the post-stent imaging run

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=150 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run OCT/IVUS Result Acceptable (Yes)	53 Participants	78 Participants	0 Participants
Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run OCT/IVUS Result Acceptable (No)	97 Participants	62 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 1 hour post-procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Median Intra-stent Lumen Area (Intra-stent Flow Area)	5.54 mm^2 Interval 4.34 to 7.05	5.71 mm^2 Interval 4.59 to 7.58	5.42 mm^2 Interval 4.25 to 6.36

SECONDARY outcome

Timeframe: Up to 1 hour post-procedure

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Effective lumen area (Total flow area) is defined as Intra-stent Lumen Area plus any area of malapposition between the stent and the vessel wall (lumen border/plaque border).

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Median Effective Lumen Area (Total Flow Area)	5.68 mm^2 Interval 4.59 to 7.3	5.87 mm^2 Interval 4.76 to 7.59	5.52 mm^2 Interval 4.42 to 6.63

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) Major	35 Participants	15 Participants	0 Participants
IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) Minor	18 Participants	7 Participants	0 Participants
IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) All (Major and Minor)	53 Participants	22 Participants	0 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) Major	28 Participants	20 Participants	0 Participants
IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) Minor	24 Participants	7 Participants	0 Participants
IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) All (Major and Minor)	52 Participants	27 Participants	0 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=135 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=140 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) Major	27 Participants	10 Participants	0 Participants
IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) Minor	73 Participants	17 Participants	0 Participants
IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) All (Major and Minor)	100 Participants	27 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter	0.99 mm Interval 0.7 to 1.24	1.03 mm Interval 0.73 to 1.26	0.95 mm Interval 0.68 to 1.21

SECONDARY outcome

Timeframe: Final Post-PCI, up to 1 hour after PCI procedure

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter In-stent	2.71 mm Interval 2.4 to 3.05	2.78 mm Interval 2.54 to 3.09	2.71 mm Interval 2.44 to 2.96
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter In-segment	2.30 mm Interval 2.03 to 2.59	2.41 mm Interval 2.12 to 2.74	2.37 mm Interval 2.11 to 2.6

SECONDARY outcome

Timeframe: Baseline

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Angiographic Endpoints (QCA) will be assessed as diameter stenosis

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis	64.1 percentage of Diameter Stenosis Interval 55.8 to 73.1	63.7 percentage of Diameter Stenosis Interval 56.0 to 73.0	66.0 percentage of Diameter Stenosis Interval 57.8 to 74.9

SECONDARY outcome

Timeframe: Final Post-PCI, up to 1 hour after PCI procedure

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Angiographic Endpoints (QCA) will be assessed as diameter stenosis

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis In-stent	5.0 percentage of Diameter Stenosis Interval 2.2 to 10.6	5.1 percentage of Diameter Stenosis Interval 2.6 to 8.6	6.2 percentage of Diameter Stenosis Interval 2.5 to 9.9
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis In-segment	14.7 percentage of Diameter Stenosis Interval 9.6 to 22.9	13.4 percentage of Diameter Stenosis Interval 9.0 to 20.3	13.0 percentage of Diameter Stenosis Interval 8.7 to 18.2

SECONDARY outcome

Timeframe: Final Post-PCI, up to 1 hour after PCI procedure

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention In-stent	1.76 mm Interval 1.45 to 2.05	1.75 mm Interval 1.52 to 2.1	1.75 mm Interval 1.48 to 2.04
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention In-segment	1.32 mm Interval 1.02 to 1.65	1.38 mm Interval 1.15 to 1.71	1.36 mm Interval 1.16 to 1.69

SECONDARY outcome

Timeframe: Baseline

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio	2.78 mm Interval 2.42 to 3.12	2.87 mm Interval 2.56 to 3.17	2.76 mm Interval 2.5 to 3.15

SECONDARY outcome

Timeframe: Final Post-PCI, up to 1 hour after PCI procedure

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio	2.82 mm Interval 2.47 to 3.13	2.84 mm Interval 2.58 to 3.17	2.72 mm Interval 2.45 to 3.04

SECONDARY outcome

Timeframe: Final Post-PCI, up to 1 hour after PCI procedure

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Median Total Stent Length will be measured in millimeters.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Procedural Endpoints (Site Reported): Median Total Stent Length	23.5 mm Interval 15.0 to 32.0	24.0 mm Interval 16.0 to 32.0	20.0 mm Interval 16.0 to 30.0

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Median Stents per lesion will be measured in counts

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Procedural Endpoints (Site Reported): Median Stents Per Lesion	1 Stents per lesion Interval 1.0 to 1.0	1 Stents per lesion Interval 1.0 to 1.0	1 Stents per lesion Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Median Maximal stent size will be measured in millimeters.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Procedural Endpoints (Site Reported) - Median Maximal Stent Size	3.00 mm Interval 2.75 to 3.5	3.00 mm Interval 2.75 to 3.5	3.00 mm Interval 2.75 to 3.5

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Post dilatation inflations will be assessed in terms of use of balloon inflations

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations	2 Number of inflations Interval 1.0 to 3.0	2 Number of inflations Interval 1.0 to 3.0	1 Number of inflations Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Median Maximum inflation pressure will be measured in atm.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.)	18 atm Interval 16.0 to 20.0	20 atm Interval 16.0 to 20.0	18 atm Interval 16.0 to 20.0

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Participants will be analyzed for the use of additional inventions Additional interventions used on the basis of the post stent imaging run will be either use of Larger Balloon, Use of Higher Inflation Pressures, Use of Additional Inflations, Use of Additional Stent(s), Thrombus Aspiration, or Other Interventions

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions Larger Diameter Balloon	51 Participants	28 Participants	0 Participants
Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions Higher Pressure Balloon	57 Participants	40 Participants	0 Participants
Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions Additional Stent	11 Participants	12 Participants	0 Participants
Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions Other interventions	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Angiography defined procedural success rate is defined as a final lesion angiographic diameter stenosis \<30% (QCA) and TIMI III flow (QCA) without dissection ≥ NHLBI type C, perforation, prolonged chest pain or ST segment elevation or depression changes (\>30 minutes), or procedural death.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate	135 Participants	130 Participants	131 Participants

SECONDARY outcome

Timeframe: During procedure, an average of 1 hour

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Device success rate (site reported): Successful OCT or IVUS imaging obtained pre and post PCI in the respective arms (does not include blinded OCT runs in the IVUS and Angiography arms)

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate	149 Participants	139 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.

Target Lesion Failure (TLF) at 1 year defined as cardiovascular death, target vessel myocardial infarction, or ischemia driven target-lesion revascularization. Target lesion is defined as the lesion designated for randomization to OCT vs. IVUS vs. Angiography.

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=158 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF)	4 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 Year

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year

Outcome measures

Outcome measures
Measure	Coronary PCI Guided by OCT n=156 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type	Coronary PCI Guided by IVUS n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type	Coronary PCI Guided by Angiography n=146 Participants Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type
Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction	1 Participants	1 Participants	0 Participants

Adverse Events

Coronary PCI Guided by OCT

Serious events: 37 serious events

Other events: 0 other events

Deaths: 2 deaths

Coronary PCI Guided by IVUS

Serious events: 25 serious events

Other events: 0 other events

Deaths: 2 deaths

Coronary PCI Guided by Angiography

Serious events: 26 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Kristina M Gibbens, Senior Clinical Project Manager

Abbott

Phone: +1 651-756-3859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place