OPTIMIZE IDE for the Treatment of ACS
Purpose
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
Condition
- Acute Coronary Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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;
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Svelte |
|
|
Active Comparator Control |
|
More Details
- Status
- Terminated
- Sponsor
- Svelte Medical Systems, Inc.