OPTIMIZE IDE for the Treatment of ACS

Stopped early · Not applicable

Conditions studied: Acute Coronary Syndrome

In brief

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

Key facts

Study ID

NCT03190473

Run by

Svelte Medical Systems, Inc.

People needed

1630

Starts

2018-01-02

Expected to finish

2023-03-08

Last updated by the study team

2023-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• 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
• Thomas Hospital — Fairhope, Alabama, United States

Full record on ClinicalTrials.gov

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