Coronary Artery Disease
Conditions
Keywords
Percutaneous Coronary Intervention, Intravascular Ultrasound, Optical Coherence Tomography, SJM-CIP-10034
Brief summary
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
Detailed description
This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States. Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group and IVUS groups will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups. After hospital discharge, all patients will have clinical follow-up at 30 days, and 1 year.
Interventions
PROCEDURECoronary PCI guided by IVUS
Imaging type
PROCEDURECoronary PCI guided by OCT
Imaging type
PROCEDURECoronary PCI guided by Angiography
Imaging type
Sponsors
Cardiovascular Research Foundation, New York
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
For those subjects randomized to the IVUS or Angiography treatment arms, the operating investigator at the site was blinded to the final post-PCI OCT run for the subject.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Age ≥ 18 years. 2. Patient with an indication for PCI including: * Angina (stable or unstable), * Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), * NSTEMI, or * Recent STEMI (\>24 hours from initial presentation and stable). 3. Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES) 4. Signed written informed consent Angiographic inclusion criteria: 1. The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤3.50 mm. 2. Lesion length \<40mm General
Exclusion criteria
1. Estimated creatinine clearance \<30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis 2. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital. 3. PCI within 24 hours preceding the study procedure. 4. PCI of a lesion within the target vessel within 12 months prior to the study procedure 5. Planned use of bare metal stent (BMS) 6. Planned use of bioresorbable vascular scaffold (BVS) 7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP, at time of procedure. 8. Mobitz II second degree or complete heart block 9. Malignant ventricular arrhythmias requiring treatment 10. Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (\>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema 11. Subject is intubated. 12. Known LVEF \<30%. 13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis) 14. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA. 15. Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes. 16. Known allergy to protocol-required concomitant medications including aspirin; clopidogrel, prasugrel, and ticagrelor; heparin and bivalirudin; or iodinated contrast that cannot be adequately pre-medicated. 17. Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint. 18. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment). Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) | Post-procedure within 1 hour | 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. |
| Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | During procedure, an average of 1 hour | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Post-PCI Stent Expansion (%) | Up to 1 hour post-procedure | Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100. |
| Rate of Mean Stent Expansion (%) | During procedure, an average of 1 hour | 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. |
| Number of Participants With Plaque Protrusion and Thrombus | During procedure, an average of 1 hour | 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% |
| Number of Participants With Untreated Reference Segment Disease | During procedure, an average of 1 hour | 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. |
| Number of Participants With Edge Dissections | During procedure, an average of 1 hour | 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 |
| Number of Participants With Border Detection (OCT Arm Only) | Pre-PCI OCT Run procedure | 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 |
| IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | During procedure, an average of 1 hour | Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | Baseline | Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter |
| Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | During procedure, an average of 1 hour | Clinical decision making will be assessed on the basis of the post-stent imaging run |
| Median Intra-stent Lumen Area (Intra-stent Flow Area) | Up to 1 hour post-procedure | Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion |
| Median Effective Lumen Area (Total Flow Area) | Up to 1 hour post-procedure | 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). |
| IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | During procedure, an average of 1 hour | Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts |
| IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | During procedure, an average of 1 hour | Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts |
| Number of Participants With Stent Malapposition | During procedure, an average of 1 hour | 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 |
| Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | Final Post-PCI, up to 1 hour after PCI procedure | Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | Baseline | 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. |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B | Final Post-PCI, up to 1 hour after PCI procedure | Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B |
| Procedural Endpoints (Site Reported): Median Total Stent Length | During procedure, an average of 1 hour | Median Total Stent Length will be measured in millimeters. |
| Procedural Endpoints (Site Reported): Median Stents Per Lesion | During procedure, an average of 1 hour | Median Stents per lesion will be measured in counts |
| Procedural Endpoints (Site Reported) - Median Maximal Stent Size | During procedure, an average of 1 hour | Median Maximal stent size will be measured in millimeters. |
| Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations | During procedure, an average of 1 hour | Post dilatation inflations will be assessed in terms of use of balloon inflations |
| Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) | During procedure, an average of 1 hour | Median Maximum inflation pressure will be measured in atm. |
| Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | During procedure, an average of 1 hour | 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 |
| Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate | During procedure, an average of 1 hour | 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. |
| Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate | During procedure, an average of 1 hour | 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) |
| Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) | 1 year | 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. |
| Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction | 1 Year | Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | Baseline | Angiographic Endpoints (QCA) will be assessed as diameter stenosis |
| Number of Participants With Acute Procedural Success | During procedure, an average of 1 hour | 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. |
Countries
Belgium, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 158 |
| 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 | 146 |
| 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 | 146 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 2 | 0 |
| Overall Study | Lost to Follow-up | 3 | 8 | 4 |
Baseline characteristics
| Characteristic | Coronary PCI Guided by OCT | Coronary PCI Guided by IVUS | Coronary PCI Guided by Angiography | Total |
|---|---|---|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 9.3 | 65.8 years STANDARD_DEVIATION 9.5 | 65.4 years STANDARD_DEVIATION 11.2 | 65.6 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Belgium | 1 participants | 2 participants | 1 participants | 4 participants |
| Region of Enrollment Germany | 4 participants | 3 participants | 3 participants | 10 participants |
| Region of Enrollment Italy | 32 participants | 31 participants | 32 participants | 95 participants |
| Region of Enrollment Japan | 16 participants | 15 participants | 13 participants | 44 participants |
| Region of Enrollment Netherlands | 3 participants | 2 participants | 1 participants | 6 participants |
| Region of Enrollment Spain | 9 participants | 8 participants | 8 participants | 25 participants |
| Region of Enrollment United Kingdom | 4 participants | 4 participants | 3 participants | 11 participants |
| Region of Enrollment United States | 89 participants | 81 participants | 85 participants | 255 participants |
| Sex: Female, Male Female | 49 Participants | 39 Participants | 39 Participants | 127 Participants |
| Sex: Female, Male Male | 109 Participants | 107 Participants | 107 Participants | 323 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 158 | 2 / 146 | 0 / 146 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 37 / 158 | 25 / 146 | 26 / 146 |
Outcome results
Primary
Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA)
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.
Time frame: Post-procedure within 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) | 5.79 mm^2 |
| Coronary PCI Guided by IVUS | Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) | 5.89 mm^2 |
| Coronary PCI Guided by Angiography | Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) | 5.49 mm^2 |
Primary
Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event)
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).
Time frame: During procedure, an average of 1 hour
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Additional Stent implantation | 4 Participants |
| Coronary PCI Guided by OCT | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Prolonged Balloon Inflations | 0 Participants |
| Coronary PCI Guided by OCT | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Pericardiocentesis | 0 Participants |
| Coronary PCI Guided by OCT | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Thrombus Aspiration | 0 Participants |
| Coronary PCI Guided by OCT | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Intra-Procedural Complications Required Active Interventions | 4 Participants |
| Coronary PCI Guided by OCT | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Other Interventions | 0 Participants |
| Coronary PCI Guided by IVUS | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Prolonged Balloon Inflations | 0 Participants |
| Coronary PCI Guided by IVUS | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Intra-Procedural Complications Required Active Interventions | 1 Participants |
| Coronary PCI Guided by IVUS | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Additional Stent implantation | 1 Participants |
| Coronary PCI Guided by IVUS | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Pericardiocentesis | 0 Participants |
| Coronary PCI Guided by IVUS | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Thrombus Aspiration | 0 Participants |
| Coronary PCI Guided by IVUS | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Other Interventions | 0 Participants |
| Coronary PCI Guided by Angiography | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Prolonged Balloon Inflations | 0 Participants |
| Coronary PCI Guided by Angiography | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Other Interventions | 0 Participants |
| Coronary PCI Guided by Angiography | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Intra-Procedural Complications Required Active Interventions | 1 Participants |
| Coronary PCI Guided by Angiography | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Thrombus Aspiration | 0 Participants |
| Coronary PCI Guided by Angiography | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Additional Stent implantation | 1 Participants |
| Coronary PCI Guided by Angiography | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Pericardiocentesis | 0 Participants |
Secondary
Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate
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.
Time frame: During procedure, an average of 1 hour
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary PCI Guided by OCT | Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate | 135 Participants |
| Coronary PCI Guided by IVUS | Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate | 130 Participants |
| Coronary PCI Guided by Angiography | Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate | 131 Participants |
Secondary
Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate
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)
Time frame: During procedure, an average of 1 hour
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary PCI Guided by OCT | Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate | 149 Participants |
| Coronary PCI Guided by IVUS | Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate | 139 Participants |
| Coronary PCI Guided by Angiography | Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate | 0 Participants |
Secondary
Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction
Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year
Time frame: 1 Year
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary PCI Guided by OCT | Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction | 1 Participants |
| Coronary PCI Guided by IVUS | Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction | 1 Participants |
| Coronary PCI Guided by Angiography | Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction | 0 Participants |
Secondary
Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF)
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.
Time frame: 1 year
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary PCI Guided by OCT | Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) | 4 Participants |
| Coronary PCI Guided by IVUS | Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) | 6 Participants |
| Coronary PCI Guided by Angiography | Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) | 2 Participants |
Secondary
IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only)
Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | All (Major and Minor) | 53 Participants |
| Coronary PCI Guided by OCT | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 35 Participants |
| Coronary PCI Guided by OCT | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 18 Participants |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | All (Major and Minor) | 22 Participants |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 7 Participants |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 15 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | All (Major and Minor) | 0 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 0 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 0 Participants |
Secondary
IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only)
Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 24 Participants |
| Coronary PCI Guided by OCT | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 28 Participants |
| Coronary PCI Guided by OCT | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | All (Major and Minor) | 52 Participants |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 7 Participants |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 20 Participants |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | All (Major and Minor) | 27 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 0 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | All (Major and Minor) | 0 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 0 Participants |
Secondary
IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only)
Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 73 Participants |
| Coronary PCI Guided by OCT | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 27 Participants |
| Coronary PCI Guided by OCT | 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 |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 17 Participants |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 10 Participants |
| Coronary PCI Guided by IVUS | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | All (Major and Minor) | 27 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | Major | 0 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | All (Major and Minor) | 0 Participants |
| Coronary PCI Guided by Angiography | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | Minor | 0 Participants |
Secondary
Median Effective Lumen Area (Total Flow Area)
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).
Time frame: Up to 1 hour post-procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Median Effective Lumen Area (Total Flow Area) | 5.68 mm^2 |
| Coronary PCI Guided by IVUS | Median Effective Lumen Area (Total Flow Area) | 5.87 mm^2 |
| Coronary PCI Guided by Angiography | Median Effective Lumen Area (Total Flow Area) | 5.52 mm^2 |
Secondary
Median Intra-stent Lumen Area (Intra-stent Flow Area)
Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion
Time frame: Up to 1 hour post-procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Median Intra-stent Lumen Area (Intra-stent Flow Area) | 5.54 mm^2 |
| Coronary PCI Guided by IVUS | Median Intra-stent Lumen Area (Intra-stent Flow Area) | 5.71 mm^2 |
| Coronary PCI Guided by Angiography | Median Intra-stent Lumen Area (Intra-stent Flow Area) | 5.42 mm^2 |
Secondary
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention
Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | In-stent | 1.76 mm |
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | In-segment | 1.32 mm |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | In-stent | 1.75 mm |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | In-segment | 1.38 mm |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | In-stent | 1.75 mm |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | In-segment | 1.36 mm |
Secondary
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
Angiographic Endpoints (QCA) will be assessed as diameter stenosis
Time frame: Baseline
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | 64.1 percentage of Diameter Stenosis |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | 63.7 percentage of Diameter Stenosis |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | 66.0 percentage of Diameter Stenosis |
Secondary
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis
Angiographic Endpoints (QCA) will be assessed as diameter stenosis
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | In-stent | 5.0 percentage of Diameter Stenosis |
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | In-segment | 14.7 percentage of Diameter Stenosis |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | In-stent | 5.1 percentage of Diameter Stenosis |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | In-segment | 13.4 percentage of Diameter Stenosis |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | In-stent | 6.2 percentage of Diameter Stenosis |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | In-segment | 13.0 percentage of Diameter Stenosis |
Secondary
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | 2.82 mm |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | 2.84 mm |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | 2.72 mm |
Secondary
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio
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.
Time frame: Baseline
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | 2.78 mm |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | 2.87 mm |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | 2.76 mm |
Secondary
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter
Time frame: Baseline
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | 0.99 mm |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | 1.03 mm |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | 0.95 mm |
Secondary
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter
Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | In-stent | 2.71 mm |
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | In-segment | 2.30 mm |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | In-stent | 2.78 mm |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | In-segment | 2.41 mm |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | In-stent | 2.71 mm |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | In-segment | 2.37 mm |
Secondary
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B
Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary PCI Guided by OCT | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B | 1 Participants |
| Coronary PCI Guided by IVUS | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B | 1 Participants |
| Coronary PCI Guided by Angiography | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B | 1 Participants |
Secondary
Number of Participants With Acute Procedural Success
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.
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Number of Participants With Acute Procedural Success | Unacceptable (<90%) | 82 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Acute Procedural Success | Acceptable (90 to 95%) | 22 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Acute Procedural Success | Optimal (≥95%) | 36 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Acute Procedural Success | Acceptable (90 to 95%) | 16 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Acute Procedural Success | Optimal (≥95%) | 32 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Acute Procedural Success | Unacceptable (<90%) | 82 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Acute Procedural Success | Optimal (≥95%) | 23 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Acute Procedural Success | Unacceptable (<90%) | 108 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Acute Procedural Success | Acceptable (90 to 95%) | 5 Participants |
Secondary
Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run
Clinical decision making will be assessed on the basis of the post-stent imaging run
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | OCT/IVUS Result Acceptable (Yes) | 53 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | OCT/IVUS Result Acceptable (No) | 97 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | OCT/IVUS Result Acceptable (Yes) | 78 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | OCT/IVUS Result Acceptable (No) | 62 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | OCT/IVUS Result Acceptable (Yes) | 0 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | OCT/IVUS Result Acceptable (No) | 0 Participants |
Secondary
Number of Participants With Border Detection (OCT Arm Only)
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
Time frame: Pre-PCI OCT Run procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Number of Participants With Border Detection (OCT Arm Only) | Moderate >=1800, <2700 of Visible EEL Circumference | 28 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Border Detection (OCT Arm Only) | Poor <180º of Visible EEL Circumference | 7 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Border Detection (OCT Arm Only) | Good >=2700 of Visible EEL Circumference | 109 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Border Detection (OCT Arm Only) | Moderate >=1800, <2700 of Visible EEL Circumference | 0 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Border Detection (OCT Arm Only) | Poor <180º of Visible EEL Circumference | 0 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Border Detection (OCT Arm Only) | Good >=2700 of Visible EEL Circumference | 0 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Border Detection (OCT Arm Only) | Poor <180º of Visible EEL Circumference | 0 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Border Detection (OCT Arm Only) | Good >=2700 of Visible EEL Circumference | 0 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Border Detection (OCT Arm Only) | Moderate >=1800, <2700 of Visible EEL Circumference | 0 Participants |
Secondary
Number of Participants With Edge Dissections
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
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Number of Participants With Edge Dissections | Major | 19 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Edge Dissections | Minor | 20 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Edge Dissections | All (Major and Minor) | 39 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Edge Dissections | Intimal | 16 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Edge Dissections | Medial | 27 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Edge Dissections | Adventitial | 1 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Edge Dissections | Adventitial | 0 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Edge Dissections | Major | 35 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Edge Dissections | Intimal | 11 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Edge Dissections | Medial | 45 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Edge Dissections | Minor | 18 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Edge Dissections | All (Major and Minor) | 53 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Edge Dissections | Minor | 35 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Edge Dissections | All (Major and Minor) | 61 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Edge Dissections | Adventitial | 0 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Edge Dissections | Intimal | 21 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Edge Dissections | Major | 26 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Edge Dissections | Medial | 40 Participants |
Secondary
Number of Participants With Plaque Protrusion and Thrombus
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%
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Number of Participants With Plaque Protrusion and Thrombus | Major | 27 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Plaque Protrusion and Thrombus | Minor | 67 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Plaque Protrusion and Thrombus | Major | 27 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Plaque Protrusion and Thrombus | Minor | 73 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Plaque Protrusion and Thrombus | Major | 25 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Plaque Protrusion and Thrombus | Minor | 70 Participants |
Secondary
Number of Participants With Stent Malapposition
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
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Number of Participants With Stent Malapposition | Minor | 43 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Stent Malapposition | Major | 15 Participants |
| Coronary PCI Guided by OCT | Number of Participants With Stent Malapposition | All (Major and Minor) | 58 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Stent Malapposition | Minor | 24 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Stent Malapposition | Major | 28 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Stent Malapposition | All (Major and Minor) | 52 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Stent Malapposition | Major | 44 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Stent Malapposition | All (Major and Minor) | 83 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Stent Malapposition | Minor | 39 Participants |
Secondary
Number of Participants With Untreated Reference Segment Disease
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.
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary PCI Guided by OCT | Number of Participants With Untreated Reference Segment Disease | 44 Participants |
| Coronary PCI Guided by IVUS | Number of Participants With Untreated Reference Segment Disease | 45 Participants |
| Coronary PCI Guided by Angiography | Number of Participants With Untreated Reference Segment Disease | 39 Participants |
Secondary
Procedural Endpoints (Site Reported) - Median Maximal Stent Size
Median Maximal stent size will be measured in millimeters.
Time frame: During procedure, an average of 1 hour
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported) - Median Maximal Stent Size | 3.00 mm |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported) - Median Maximal Stent Size | 3.00 mm |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported) - Median Maximal Stent Size | 3.00 mm |
Secondary
Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.)
Median Maximum inflation pressure will be measured in atm.
Time frame: During procedure, an average of 1 hour
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) | 18 atm |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) | 20 atm |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) | 18 atm |
Secondary
Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations
Post dilatation inflations will be assessed in terms of use of balloon inflations
Time frame: During procedure, an average of 1 hour
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations | 2 Number of inflations |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations | 2 Number of inflations |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations | 1 Number of inflations |
Secondary
Procedural Endpoints (Site Reported): Median Stents Per Lesion
Median Stents per lesion will be measured in counts
Time frame: During procedure, an average of 1 hour
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported): Median Stents Per Lesion | 1 Stents per lesion |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported): Median Stents Per Lesion | 1 Stents per lesion |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported): Median Stents Per Lesion | 1 Stents per lesion |
Secondary
Procedural Endpoints (Site Reported): Median Total Stent Length
Median Total Stent Length will be measured in millimeters.
Time frame: During procedure, an average of 1 hour
Population: Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported): Median Total Stent Length | 23.5 mm |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported): Median Total Stent Length | 24.0 mm |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported): Median Total Stent Length | 20.0 mm |
Secondary
Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions
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
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Larger Diameter Balloon | 51 Participants |
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Higher Pressure Balloon | 57 Participants |
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Additional Stent | 11 Participants |
| Coronary PCI Guided by OCT | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Other interventions | 1 Participants |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Other interventions | 1 Participants |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Larger Diameter Balloon | 28 Participants |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Additional Stent | 12 Participants |
| Coronary PCI Guided by IVUS | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Higher Pressure Balloon | 40 Participants |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Other interventions | 0 Participants |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Higher Pressure Balloon | 0 Participants |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Additional Stent | 0 Participants |
| Coronary PCI Guided by Angiography | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Larger Diameter Balloon | 0 Participants |
Secondary
Rate of Mean Stent Expansion (%)
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.
Time frame: During procedure, an average of 1 hour
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Coronary PCI Guided by OCT | Rate of Mean Stent Expansion (%) | 105.8 percentage of mean stent expansion |
| Coronary PCI Guided by IVUS | Rate of Mean Stent Expansion (%) | 106.3 percentage of mean stent expansion |
| Coronary PCI Guided by Angiography | Rate of Mean Stent Expansion (%) | 101.4 percentage of mean stent expansion |
Secondary
Rate of Post-PCI Stent Expansion (%)
Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100.
Time frame: Up to 1 hour post-procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coronary PCI Guided by OCT | Rate of Post-PCI Stent Expansion (%) | 87.6 percentage of stent expansion | Standard Deviation 16.6 |
| Coronary PCI Guided by IVUS | Rate of Post-PCI Stent Expansion (%) | 86.5 percentage of stent expansion | Standard Deviation 15.9 |
| Coronary PCI Guided by Angiography | Rate of Post-PCI Stent Expansion (%) | 82.9 percentage of stent expansion | Standard Deviation 12.9 |