OPTIMIZE IDE for the Treatment of ACS

NCT ID: NCT03190473

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2023-03-08

Brief Summary

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Svelte

Group Type: EXPERIMENTAL

DES

Intervention Type: DEVICE

PCI with implantation of a DES

Control

Group Type: ACTIVE_COMPARATOR

DES

Intervention Type: DEVICE

PCI with implantation of a DES

Interventions

DES

PCI with implantation of a DES

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is an eligible candidate for percutaneous coronary intervention (PCI);
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG);

Exclusion Criteria

• Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;

• The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;
• The subject's target lesion(s) is located in the left main artery;
• The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate;
• The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;
• The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Svelte Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shing C Wong, MD

Role: STUDY_DIRECTOR

Svelte Medical

Locations

Thomas Hospital

Fairhope, Alabama, United States

Scottsdale Healthcare

Scottsdale, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Bakersfield Memorial Hospital

Bakersfield, California, United States

Mission Cardiovascular Research Institute (Washington Hospital)

Fremont, California, United States

Long Beach VA Medical Center

Long Beach, California, United States

Keck Hospital of USC

Los Angeles, California, United States

San Francisco VA

San Francisco, California, United States

Christiana Hospital

Newark, Delaware, United States

Morton Plant Hospital

Clearwater, Florida, United States

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Memorial Regional Hospital

Hollywood, Florida, United States

University of Miami Medical Center

Miami, Florida, United States

Mediquest (Munroe Regional Medical Center)

Ocala, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Jesse Brown VAMC

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Amita/Adventist Heart and Vascular

Hinsdale, Illinois, United States

Elkhart General Healthcare

Elkhart, Indiana, United States

St Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Mercy Hospital Medical Center

Des Moines, Iowa, United States

Union Memorial Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Borgess Heart Center

Kalamazoo, Michigan, United States

Northern Michigan Hospital d.b.a McLaren Northern Michigan

Petoskey, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

St. Mary's Duluth Clinic

Duluth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

North Mississippi Health Services

Tupelo, Mississippi, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

NYU Winthrop Hospital

Mineola, New York, United States

NYU Langone Medical Center

New York, New York, United States

Weill Cornell Medical Center

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

St. Joseph's Hospital Health Center

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Durham VA Medical Center

Durham, North Carolina, United States

Moses Cone Memorial Hospital

Greensboro, North Carolina, United States

North Carolina Heart and Vascular

Raleigh, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Hershey Medical Center

Hershey, Pennsylvania, United States

Robert Packer Hospital

Sayre, Pennsylvania, United States

Texas Heart Institute

Houston, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Austin Heart

Round Rock, Texas, United States

South Texas Cardiology Institute

San Antonio, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Swedish Hospital Medical Center

Seattle, Washington, United States

Shonan Kamakura General Hospital

Kamakura, , Japan

Kanazawa Cardiovascular Hospital

Kanazawa, , Japan

Kokura Memorial Hospital

Kitakyushu, , Japan

Medical Corporation Association Sakura Association Takahashi Hospital

Kobe, , Japan

Ohara Healthcare Foundation Kurashiki Central Hospital

Kurashiki, , Japan

Shin Koga Hospital

Kurume, , Japan

Miyazaki Medical Association

Miyazaki, , Japan

The Sakakibara Heart Institute of Okayama

Okayama, , Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, , Japan

Meander Medisch Centrum

Amersfoort, , Netherlands

OLVG loc Oost

Amsterdam, , Netherlands

Tergooi Ziekenhuis

Blaricum, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

HAGA Ziekenhuis

The Hague, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Countries

United States; Japan; Netherlands

References

Kereiakes DJ, Feldman RL, Ijsselmuiden AJJ, Saito S, Amoroso G, Zidar JP, Wong SC, Stella P, Yakubov S, Lasala J, Cohen DJ, Doros G, Cutlip DE, Rao SV. Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study. Circ Cardiovasc Interv. 2021 Sep;14(9):e010609. doi: 10.1161/CIRCINTERVENTIONS.121.010609. Epub 2021 Aug 6.

Reference Type: DERIVED

PMID: 34353122 (View on PubMed)

Mauri L, Doros G, Rao SV, Cohen DJ, Yakubov S, Lasala J, Wong SC, Zidar J, Kereiakes DJ. The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale. Am Heart J. 2019 Oct;216:82-90. doi: 10.1016/j.ahj.2019.07.003. Epub 2019 Jul 13.

Reference Type: DERIVED

PMID: 31415994 (View on PubMed)

Other Identifiers

IP-15-001

Identifier Type: -

Identifier Source: org_study_id