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

Abbott Medical Devices450 enrolled

Overview

The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

450

Conditions

Coronary Artery Disease

Interventions

Coronary PCI guided by IVUSPROCEDURE

Imaging type

Coronary PCI guided by OCTPROCEDURE

Imaging type

Coronary PCI guided by AngiographyPROCEDURE

Imaging type

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: 1. 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 2. Left main diameter stenosis ≥30% or left main PCI planned. 3. Study target lesion in a bypass graft 4. Ostial RCA study target lesion 5. Chronic total occlusion (TIMI flow 0/1) study target lesion 6. Bifurcation study lesion with a planned dual stent strategy 7. In-stent restenosis study target lesion 8. 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)

Locations (29)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Scottsdale Healthcare Shea

Scottsdale, Arizona, United States

University of California at San Diego (UCSD) Medical Center

San Diego, California, United States

Heart Institute of Colorado

Broomfield, Colorado, United States

Orlando Health

Orlando, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Kansas University Medical Center

Kansas City, Kansas, United States

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

New York Presbyterian Hospital/Columbia University

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

...and 19 more locations

Time frame: During procedure, an average of 1 hour

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

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

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

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

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

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

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

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

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

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

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

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

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

Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter

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

Time frame: Baseline

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

Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis

Angiographic Endpoints (QCA) will be assessed as diameter stenosis

Time frame: Baseline

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

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

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

Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio

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

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

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

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

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

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

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

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

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

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

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

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