OPTIMIZE IDE for the Treatment of ACS

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: DES


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Svelte<br> | Device: DES<br>* PCI with implantation of a DES<br>|
| Active Comparator: Control<br> | Device: DES<br>* PCI with implantation of a DES<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Stent Thrombosis |  | 6 and 12 months and annually through 5 years follow-up |