OPTIMIZE IDE for the Treatment of ACS

Svelte Medical Systems

Status

Terminated

Conditions

Acute Coronary Syndrome

Treatments

Device: DES

Study type

Interventional

Funder types

Industry

Identifiers

NCT03190473

IP-15-001

Details and patient eligibility

About

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

Enrollment

1,630 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;