OPTIMIZE IDE for the Treatment of ACS
- Conditions
- Acute Coronary Syndrome
- Interventions
- Device: DES
- Registration Number
- NCT03190473
- Lead Sponsor
- Svelte Medical Systems, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1630
- 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);
- Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Svelte DES - Control DES -
- Primary Outcome Measures
Name Time Method Target Lesion Failure (TLF) 12 months
- Secondary Outcome Measures
Name Time Method Stent Thrombosis 6 and 12 months and annually through 5 years follow-up Target Vessel Failure (TVF) 6 and 12 months, and annually through 5 years Major Adverse Cardiac Event (MACE) 6 and 12 months and annually through 5 years follow-up
Trial Locations
- Locations (72)
Clearwater Cardiovascular Consultants
🇺🇸Clearwater, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
Jesse Brown VAMC
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
St Vincent Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
San Francisco VA
🇺🇸San Francisco, California, United States
Durham VA Medical Center
🇺🇸Durham, North Carolina, United States
South Texas Cardiology Institute
🇺🇸San Antonio, Texas, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Thomas Hospital
🇺🇸Fairhope, Alabama, United States
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Mission Cardiovascular Research Institute (Washington Hospital)
🇺🇸Fremont, California, United States
Bakersfield Memorial Hospital
🇺🇸Bakersfield, California, United States
Long Beach VA Medical Center
🇺🇸Long Beach, California, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Mediquest (Munroe Regional Medical Center)
🇺🇸Ocala, Florida, United States
University of Miami Medical Center
🇺🇸Miami, Florida, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Mercy Hospital Medical Center
🇺🇸Des Moines, Iowa, United States
Elkhart General Healthcare
🇺🇸Elkhart, Indiana, United States
Borgess Heart Center
🇺🇸Kalamazoo, Michigan, United States
Amita/Adventist Heart and Vascular
🇺🇸Hinsdale, Illinois, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
St. Mary's Duluth Clinic
🇺🇸Duluth, Minnesota, United States
Northern Michigan Hospital d.b.a McLaren Northern Michigan
🇺🇸Petoskey, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
North Mississippi Health Services
🇺🇸Tupelo, Mississippi, 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
Weill Cornell Medical Center
🇺🇸New York, New York, United States
NYU Langone 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
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
North Carolina Heart and Vascular
🇺🇸Raleigh, North Carolina, United States
Moses Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Robert Packer Hospital
🇺🇸Sayre, Pennsylvania, United States
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Austin Heart
🇺🇸Round Rock, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Shonan Kamakura General Hospital
🇯🇵Kamakura, Japan
Swedish Hospital Medical Center
🇺🇸Seattle, Washington, United States
Kanazawa Cardiovascular Hospital
🇯🇵Kanazawa, Japan
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
Medical Corporation Association Sakura Association Takahashi Hospital
🇯🇵Kobe, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Japan
Ohara Healthcare Foundation Kurashiki Central Hospital
🇯🇵Kurashiki, Japan
Shin Koga Hospital
🇯🇵Kurume, Japan
Miyazaki Medical Association
🇯🇵Miyazaki, Japan
Sapporo Higashi Tokushukai Hospital
🇯🇵Sapporo, Japan
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
The Sakakibara Heart Institute of Okayama
🇯🇵Okayama, Japan
OLVG loc Oost
🇳🇱Amsterdam, Netherlands
Tergooi Ziekenhuis
🇳🇱Blaricum, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
HAGA Ziekenhuis
🇳🇱Den Haag, Netherlands
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Christiana Hospital
🇺🇸Newark, Delaware, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States