OPTIMIZE IDE for the Treatment of ACS

Not Applicable

Terminated

• Conditions: Acute Coronary Syndrome

• 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

Study Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Study Start: 2018-01-02
• Primary Completion: 2020-07-17
• Status Verified: 2023-03
• Study Completion: 2023-03-08
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1630

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Thomas Hospital; 🇺🇸 Fairhope, Alabama, United States

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

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