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

NCT02471586 | Completed Results DMC

• 1 other identifier: SJM-CIP-10034
• Study Type: interventional
• Target: 450
• Locations: 8 countries
• Sites: 29

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Intravascular Ultrasound; Optical Coherence Tomography; SJM-CIP-10034

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  During procedure, an average of 1 hour

Secondary Outcomes (32)

• Number of Participants With Acute Procedural Success

  During procedure, an average of 1 hour

• Rate of Post-PCI Stent Expansion (%)

  Up to 1 hour post-procedure

• Rate of Mean Stent Expansion (%)

  During procedure, an average of 1 hour

• Number of Participants With Plaque Protrusion and Thrombus

  During procedure, an average of 1 hour

• Number of Participants With Untreated Reference Segment Disease

  During procedure, an average of 1 hour

Study Arms (3)

Coronary PCI guided by IVUS

ACTIVE COMPARATOR

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.

Procedure: Coronary PCI guided by IVUS

Coronary PCI guided by OCT

ACTIVE COMPARATOR

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.

Procedure: Coronary PCI guided by OCT

Coronary PCI guided by Angiography

ACTIVE COMPARATOR

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.

Procedure: Coronary PCI guided by Angiography

Interventions

Coronary PCI guided by IVUS PROCEDURE

Imaging type

Also known as: Intravascular Ultrasound

Coronary PCI guided by IVUS

Coronary PCI guided by OCT PROCEDURE

Imaging type

Also known as: Optical Coherence Tomography

Coronary PCI guided by OCT

Coronary PCI guided by Angiography PROCEDURE

Imaging type

Coronary PCI guided by Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (29)

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

Birmingham, Alabama, 35249, United States

Location

Scottsdale Healthcare Shea

Scottsdale, Arizona, 85260, United States

Location

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92037, United States

Location

Heart Institute of Colorado

Broomfield, Colorado, 80021, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

New York Presbyterian Hospital/Columbia University

New York, New York, 10032, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Eastern Cardiology

Greenville, North Carolina, 27834, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

St. Charles Medical Center

Bend, Oregon, 97701, United States

Location

Austin Heart

Austin, Texas, 78705, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

The University of Texas Health Science at San Antonio

San Antonio, Texas, 78229, United States

Location

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, East Flanders, 9300, Belgium

Location

Klinikum der Justus-Liebig-Universität

Giessen, Hesse, 35392, Germany

Location

Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

Location

Centro Cardiologico Monzino

Milan, Lombardy, 20138, Italy

Location

Kobe University Hospital

Chuo-ku, Hyōgo, 650-0017, Japan

Location

Nara Medical University Hospital

Kashihara-shi, Nara, 634-8521, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, 530-0012, Japan

Location

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510, Japan

Location

Yamaguchi University Hospital

Ube-shi, Yamaguchi, 755-0046, Japan

Location

Erasmus MC - Thoraxcenter

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Kings College Hospital

Brixton, London, SE5 9RS, United Kingdom

Location

Related Publications (2)

• Ali ZA, Karimi Galougahi K, Maehara A, Shlofmitz RA, Fabbiocchi F, Guagliumi G, Alfonso F, Akasaka T, Matsumura M, Mintz GS, Ben-Yehuda O, Zhang Z, Rapoza RR, West NEJ, Stone GW. Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial. EuroIntervention. 2021 Jan 20;16(13):1085-1091. doi: 10.4244/EIJ-D-20-00498.

  PMID: 32540793 DERIVED

• Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30.

  PMID: 27806900 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ultrasonography, Interventional; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Tomography, Optical; Optical Imaging; Tomography; Investigative Techniques

Results Point of Contact

• Title: Kristina M Gibbens, Senior Clinical Project Manager
• Organization: Abbott

Kristina.gibbens@abbott.com

+1 651-756-3859

Study Officials

• Ziad Ali, MD

  Columbia Presbyterian Medical Center (NY)

  PRINCIPAL INVESTIGATOR

• Gregg W Stone, MD

  Columbia Presbyterian Medical Center (NY)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: June 15, 2015
• Study Start: May 1, 2015
• Primary Completion: April 5, 2016
• Study Completion: April 25, 2017
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (17); DE (1); NL (1); GB (1); IT (2); JP (5); ES (1)