OPTIMIZE IDE for the Treatment of ACS (OPTIMIZE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03190473 |
Recruitment Status :
Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : August 4, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome | Device: DES | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1630 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | January 2, 2018 |
Actual Primary Completion Date : | July 17, 2020 |
Estimated Study Completion Date : | June 28, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Svelte |
Device: DES
PCI with implantation of a DES |
Active Comparator: Control |
Device: DES
PCI with implantation of a DES |
- Target Lesion Failure (TLF) [ Time Frame: 12 months ]
- Target Vessel Failure (TVF) [ Time Frame: 6 and 12 months, and annually through 5 years ]
- Major Adverse Cardiac Event (MACE) [ Time Frame: 6 and 12 months and annually through 5 years follow-up ]
- Stent Thrombosis [ Time Frame: 6 and 12 months and annually through 5 years follow-up ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190473

Study Director: | Dennis Donohoe, MD | Svelte Medical |
Responsible Party: | Svelte Medical Systems, Inc. |
ClinicalTrials.gov Identifier: | NCT03190473 |
Other Study ID Numbers: |
IP-15-001 |
First Posted: | June 16, 2017 Key Record Dates |
Last Update Posted: | August 4, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |