OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Procedure: Coronary PCI guided by OCT
Procedure: Coronary PCI guided by IVUS
Procedure: Coronary PCI guided by Angiography

Registration Number: NCT02471586

Lead Sponsor: Abbott Medical Devices

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 450

Inclusion Criteria

Age ≥ 18 years.
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).
Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
Signed written informed consent

Angiographic inclusion criteria:

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.
Lesion length <40mm

General

Exclusion Criteria

Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis
STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital.
PCI within 24 hours preceding the study procedure.
PCI of a lesion within the target vessel within 12 months prior to the study procedure
Planned use of bare metal stent (BMS)
Planned use of bioresorbable vascular scaffold (BVS)
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.
Mobitz II second degree or complete heart block
Malignant ventricular arrhythmias requiring treatment
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
Subject is intubated.
Known LVEF <30%.
Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes.
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.
Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment).

Angiographic Exclusion Criteria:

The presence of any non-study lesion in the target vessel with angiographic diameter stenosis >50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure
Left main diameter stenosis ≥30% or left main PCI planned.
Study target lesion in a bypass graft
Ostial RCA study target lesion
Chronic total occlusion (TIMI flow 0/1) study target lesion
Bifurcation study lesion with a planned dual stent strategy
In-stent restenosis study target lesion
Any study lesion characteristic resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel calcification or tortuosity)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coronary PCI guided by OCT	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 IVUS	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 Angiography	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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): 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
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.
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
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
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 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.
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter	Final Post-PCI, up to 1 hour after PCI procedure	Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter
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): 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 Peri-procedural Myocardial Infarction	1 Year	Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year
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 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
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
Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio	Final Post-PCI, up to 1 hour after PCI procedure	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.
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.
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
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
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 Diameter Stenosis	Final Post-PCI, up to 1 hour after PCI procedure	Angiographic Endpoints (QCA) will be assessed as diameter stenosis
Procedural Endpoints (Site Reported) - Median Maximal Stent Size	During procedure, an average of 1 hour	Median Maximal stent size will be measured in millimeters.
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.
Procedural Endpoints (Site Reported): Median Total Stent Length	During procedure, an average of 1 hour	Median Total Stent Length will be measured in millimeters.
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.

Trial Locations

Locations (29): Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Eastern Cardiology
🇺🇸
Greenville, North Carolina, United States
Scottsdale Healthcare Shea
🇺🇸
Scottsdale, Arizona, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
Heart Institute of Colorado
🇺🇸
Broomfield, Colorado, United States
University of Massachusetts Medical Center
🇺🇸
Worcester, Massachusetts, United States
New York Presbyterian Hospital/Columbia University
🇺🇸
New York, New York, United States
St. Francis Hospital
🇺🇸
Roslyn, New York, United States
Lenox Hill Hospital
🇺🇸
New York, New York, United States
St. Charles Medical Center
🇺🇸
Bend, Oregon, United States
Austin Heart
🇺🇸
Austin, Texas, United States
Nara Medical University Hospital
🇯🇵
Kashihara-shi, Nara, Japan
Osaka Saiseikai Nakatsu Hospital
🇯🇵
Osaka-shi, Osaka, Japan
Kobe University Hospital
🇯🇵
Chuo-ku, Hyogo, Japan
Yamaguchi University Hospital
🇯🇵
Ube-shi, Yamaguchi, Japan
Wakayama Medical University Hospital
🇯🇵
Wakayama City, Wakayama, Japan
Erasmus MC - Thoraxcenter
🇳🇱
Rotterdam, Zuid-Holland, Netherlands
Hospital Universitario de la Princesa
🇪🇸
Madrid, Spain
Kings College Hospital
🇬🇧
Brixton, London, United Kingdom
Klinikum der Justus-Liebig-Universität
🇩🇪
Giessen, Hesse, Germany
Centro Cardiologico Monzino
🇮🇹
Milan, Lombardy, Italy
Onze-Lieve-Vrouwziekenhuis Campus Aalst
🇧🇪
Aalst, East Flanders, Belgium
Ospedale Papa Giovanni XXIII
🇮🇹
Bergamo, Lombardy, Italy
University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸
Birmingham, Alabama, United States
University of California at San Diego (UCSD) Medical Center
🇺🇸
San Diego, California, United States
INTEGRIS Baptist Medical Center
🇺🇸
Oklahoma City, Oklahoma, United States
Memorial Hermann Hospital
🇺🇸
Houston, Texas, United States
The University of Texas Health Science at San Antonio
🇺🇸
San Antonio, Texas, United States
Orlando Health
🇺🇸
Orlando, Florida, United States