Clinical trial NCT03190473: OPTIMIZE IDE for the Treatment of ACS
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Svelte Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 1630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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;

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 6 and 12 months, and annually through 5 years
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 6 and 12 months and annually through 5 years follow-up
measure: Stent Thrombosis
timeFrame: 6 and 12 months and annually through 5 years follow-up
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute (Washington Hospital)
state: California
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: San Francisco
country: United States
facility: San Francisco VA
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Medical Center
state: Florida
city: Ocala
country: United States
facility: Mediquest (Munroe Regional Medical Center)
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Chicago
country: United States
facility: Jesse Brown VAMC
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Hinsdale
country: United States
facility: Amita/Adventist Heart and Vascular
state: Illinois
city: Elkhart
country: United States
facility: Elkhart General Healthcare
state: Indiana
city: Indianapolis
country: United States
facility: St Vincent Heart Center of Indiana
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Kalamazoo
country: United States
facility: Borgess Heart Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital d.b.a McLaren Northern Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Health Services
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Memorial Hospital
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Round Rock
country: United States
facility: Austin Heart
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiology Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Hospital Medical Center
state: Washington
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
city: Kanazawa
country: Japan
facility: Kanazawa Cardiovascular Hospital
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
city: Kobe
country: Japan
facility: Medical Corporation Association Sakura Association Takahashi Hospital
city: Kurashiki
country: Japan
facility: Ohara Healthcare Foundation Kurashiki Central Hospital
city: Kurume
country: Japan
facility: Shin Koga Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association
city: Okayama
country: Japan
facility: The Sakakibara Heart Institute of Okayama
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: OLVG loc Oost
city: Blaricum
country: Netherlands
facility: Tergooi Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Haag
country: Netherlands
facility: HAGA Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Svelte Medical
name: Shing C Wong, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Mauri 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.