Study Stopped
Company financial insolvency, not due to safety or efficacy concerns
OPTIMIZE IDE for the Treatment of ACS
OPTIMIZE
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
1 other identifier
interventional
1,630
3 countries
72
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedStudy Start
First participant enrolled
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2023
CompletedMarch 23, 2023
March 1, 2023
2.5 years
June 14, 2017
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Target Lesion Failure (TLF)
12 months
Secondary Outcomes (3)
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
Study Arms (2)
Svelte
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Thomas Hospital
Fairhope, Alabama, 36532, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Bakersfield Memorial Hospital
Bakersfield, California, 93301, United States
Mission Cardiovascular Research Institute (Washington Hospital)
Fremont, California, 94538, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
San Francisco VA
San Francisco, California, 94121, United States
Christiana Hospital
Newark, Delaware, 19702, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 34695, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
University of Miami Medical Center
Miami, Florida, 33125, United States
Mediquest (Munroe Regional Medical Center)
Ocala, Florida, 34471, United States
Tallahassee Research Institute
Tallahassee, Florida, 32303, United States
Jesse Brown VAMC
Chicago, Illinois, 60637, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Amita/Adventist Heart and Vascular
Hinsdale, Illinois, 60521, United States
Elkhart General Healthcare
Elkhart, Indiana, 46514, United States
St Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
Mercy Hospital Medical Center
Des Moines, Iowa, 50314, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Borgess Heart Center
Kalamazoo, Michigan, 49008, United States
Northern Michigan Hospital d.b.a McLaren Northern Michigan
Petoskey, Michigan, 49770, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
North Mississippi Health Services
Tupelo, Mississippi, 38801, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Rochester General Hospital
Rochester, New York, 14621, United States
St. Joseph's Hospital Health Center
Syracuse, New York, 13203, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 19103, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Texas Heart Institute
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Austin Heart
Round Rock, Texas, 78681, United States
South Texas Cardiology Institute
San Antonio, Texas, 78212, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Swedish Hospital Medical Center
Seattle, Washington, 98122, United States
Shonan Kamakura General Hospital
Kamakura, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Japan
Kokura Memorial Hospital
Kitakyushu, Japan
Medical Corporation Association Sakura Association Takahashi Hospital
Kobe, Japan
Ohara Healthcare Foundation Kurashiki Central Hospital
Kurashiki, Japan
Shin Koga Hospital
Kurume, Japan
Miyazaki Medical Association
Miyazaki, Japan
The Sakakibara Heart Institute of Okayama
Okayama, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Japan
Meander Medisch Centrum
Amersfoort, Netherlands
OLVG loc Oost
Amsterdam, Netherlands
Tergooi Ziekenhuis
Blaricum, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
St Antonius Ziekenhuis
Nieuwegein, Netherlands
HAGA Ziekenhuis
The Hague, Netherlands
UMC Utrecht
Utrecht, Netherlands
Related Publications (2)
Kereiakes DJ, Feldman RL, Ijsselmuiden AJJ, Saito S, Amoroso G, Zidar JP, Wong SC, Stella P, Yakubov S, Lasala J, Cohen DJ, Doros G, Cutlip DE, Rao SV. Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study. Circ Cardiovasc Interv. 2021 Sep;14(9):e010609. doi: 10.1161/CIRCINTERVENTIONS.121.010609. Epub 2021 Aug 6.
PMID: 34353122DERIVEDMauri L, Doros G, Rao SV, Cohen DJ, Yakubov S, Lasala J, Wong SC, Zidar J, Kereiakes DJ. The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale. Am Heart J. 2019 Oct;216:82-90. doi: 10.1016/j.ahj.2019.07.003. Epub 2019 Jul 13.
PMID: 31415994DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shing C Wong, MD
Svelte Medical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 16, 2017
Study Start
January 2, 2018
Primary Completion
July 17, 2020
Study Completion
March 8, 2023
Last Updated
March 23, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share