OPTIMIZE IDE for the Treatment of ACS

Acute Coronary Syndrome Clinical Trial

— OPTIMIZE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03190473
• Other study ID #: IP-15-001
• Status: Terminated
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2023
• Source: Svelte Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1630
• Est. completion date: March 8, 2023
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Device:
• DES
PCI with implantation of a DES

Locations

Country	Name	City	State
Japan	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
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	OLVG loc Oost	Amsterdam
Netherlands	Tergooi Ziekenhuis	Blaricum
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	HAGA Ziekenhuis	Den Haag
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	St Antonius Ziekenhuis	Nieuwegein
Netherlands	UMC Utrecht	Utrecht
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Bakersfield Memorial Hospital	Bakersfield	California
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Jesse Brown VAMC	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Morton Plant Hospital	Clearwater	Florida
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Mercy Hospital Medical Center	Des Moines	Iowa
United States	St. Mary's Duluth Clinic	Duluth	Minnesota
United States	Durham VA Medical Center	Durham	North Carolina
United States	Elkhart General Healthcare	Elkhart	Indiana
United States	Thomas Hospital	Fairhope	Alabama
United States	Mission Cardiovascular Research Institute (Washington Hospital)	Fremont	California
United States	Moses Cone Memorial Hospital	Greensboro	North Carolina
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Amita/Adventist Heart and Vascular	Hinsdale	Illinois
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Texas Heart Institute	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	St Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Borgess Heart Center	Kalamazoo	Michigan
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Long Beach VA Medical Center	Long Beach	California
United States	Keck Hospital of USC	Los Angeles	California
United States	University of Miami Medical Center	Miami	Florida
United States	NYU Winthrop Hospital	Mineola	New York
United States	Morristown Medical Center	Morristown	New Jersey
United States	NYU Langone Medical Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	Mediquest (Munroe Regional Medical Center)	Ocala	Florida
United States	Northern Michigan Hospital d.b.a McLaren Northern Michigan	Petoskey	Michigan
United States	North Carolina Heart and Vascular	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	Austin Heart	Round Rock	Texas
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	South Texas Cardiology Institute	San Antonio	Texas
United States	San Francisco VA	San Francisco	California
United States	Robert Packer Hospital	Sayre	Pennsylvania
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Swedish Hospital Medical Center	Seattle	Washington
United States	St. Joseph's Hospital Health Center	Syracuse	New York
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	North Mississippi Health Services	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Svelte Medical Systems, Inc.

Countries where clinical trial is conducted

United States,  Japan,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)		12 months
Secondary	Target Vessel Failure (TVF)		6 and 12 months, and annually through 5 years
Secondary	Major Adverse Cardiac Event (MACE)		6 and 12 months and annually through 5 years follow-up
Secondary	Stent Thrombosis		6 and 12 months and annually through 5 years follow-up