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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03190473
Other study ID # IP-15-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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