Acute Coronary Syndrome Clinical Trial
— OPTIMIZEOfficial title:
The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study
Verified date | March 2023 |
Source | Svelte Medical Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 1630 |
Est. completion date | March 8, 2023 |
Est. primary completion date | July 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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); - 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; Exclusion Criteria: - 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; |
Country | Name | City | State |
---|---|---|---|
Japan | 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 | |
Netherlands | Meander Medisch Centrum | Amersfoort | |
Netherlands | OLVG loc Oost | Amsterdam | |
Netherlands | Tergooi Ziekenhuis | Blaricum | |
Netherlands | Amphia Ziekenhuis | Breda | |
Netherlands | HAGA Ziekenhuis | Den Haag | |
Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Netherlands | St Antonius Ziekenhuis | Nieuwegein | |
Netherlands | UMC Utrecht | Utrecht | |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Bakersfield Memorial Hospital | Bakersfield | California |
United States | Union Memorial Hospital | Baltimore | Maryland |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Deborah Heart and Lung Center | Browns Mills | New Jersey |
United States | University of Virginia Medical Center | Charlottesville | Virginia |
United States | Jesse Brown VAMC | Chicago | Illinois |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Clearwater Cardiovascular Consultants | Clearwater | Florida |
United States | Morton Plant Hospital | Clearwater | Florida |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Mercy Hospital Medical Center | Des Moines | Iowa |
United States | St. Mary's Duluth Clinic | Duluth | Minnesota |
United States | Durham VA Medical Center | Durham | North Carolina |
United States | Elkhart General Healthcare | Elkhart | Indiana |
United States | Thomas Hospital | Fairhope | Alabama |
United States | Mission Cardiovascular Research Institute (Washington Hospital) | Fremont | California |
United States | Moses Cone Memorial Hospital | Greensboro | North Carolina |
United States | Hershey Medical Center | Hershey | Pennsylvania |
United States | Amita/Adventist Heart and Vascular | Hinsdale | Illinois |
United States | Memorial Regional Hospital | Hollywood | Florida |
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 | Borgess Heart Center | Kalamazoo | Michigan |
United States | St. Luke's Hospital | Kansas City | Missouri |
United States | Arkansas Heart Hospital | Little Rock | Arkansas |
United States | Long Beach VA Medical Center | Long Beach | California |
United States | Keck Hospital of USC | Los Angeles | California |
United States | University of Miami Medical Center | Miami | Florida |
United States | NYU Winthrop Hospital | Mineola | New York |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | NYU Langone Medical Center | New York | New York |
United States | Weill Cornell Medical Center | New York | New York |
United States | Christiana Hospital | Newark | Delaware |
United States | Mediquest (Munroe Regional Medical Center) | Ocala | Florida |
United States | Northern Michigan Hospital d.b.a McLaren Northern Michigan | Petoskey | Michigan |
United States | North Carolina Heart and Vascular | Raleigh | North Carolina |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Rochester General Hospital | Rochester | New York |
United States | Austin Heart | Round Rock | Texas |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | South Texas Cardiology Institute | San Antonio | Texas |
United States | San Francisco VA | San Francisco | California |
United States | Robert Packer Hospital | Sayre | Pennsylvania |
United States | Scottsdale Healthcare | Scottsdale | Arizona |
United States | Swedish Hospital Medical Center | Seattle | Washington |
United States | St. Joseph's Hospital Health Center | Syracuse | New York |
United States | Tallahassee Research Institute | Tallahassee | Florida |
United States | North Mississippi Health Services | Tupelo | Mississippi |
Lead Sponsor | Collaborator |
---|---|
Svelte Medical Systems, Inc. |
United States, Japan, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target Lesion Failure (TLF) | 12 months | ||
Secondary | Target Vessel Failure (TVF) | 6 and 12 months, and annually through 5 years | ||
Secondary | Major Adverse Cardiac Event (MACE) | 6 and 12 months and annually through 5 years follow-up | ||
Secondary | Stent Thrombosis | 6 and 12 months and annually through 5 years follow-up |
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