SELUTION 4 De Novo Small Vessel IDE Trial

Description

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Conditions

Coronary Artery Disease

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Study Overview

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Study Details

Study overview

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels

SELUTION 4 De Novo Small Vessel IDE Trial

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Thousand Oaks

HCA Los Robles, Thousand Oaks, California, United States, 91360

Torrance

Harbor UCLA, Torrance, California, United States, 90502

Golden

Colorado Heart and Vascular, Golden, Colorado, United States, 80401

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Atlantis

HCA Florida JFK, Atlantis, Florida, United States, 33462

Clearwater

Mease Countryside Hospital, Clearwater, Florida, United States, 34695

Jacksonville

University of Florida, Jacksonville, Jacksonville, Florida, United States, 32209

Largo

HCA Largo, Largo, Florida, United States, 33770

Atlanta

Atlanta VA, Atlanta, Georgia, United States, 30033

Wichita

Cardiovascular Research Institute of Kansas, Wichita, Kansas, United States, 67226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Clinical Inclusion Criteria
  • 1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
  • 2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
  • 3. Subject presents with chronic coronary syndromes \[CCS\] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention.
  • 4. Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).
  • 5. Subject has life expectancy \> 1 year in the opinion of the investigator.
  • 6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
  • * Clinical Exclusion Criteria
  • 1. Subject with known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
  • 2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
  • 3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
  • 4. Subject with planned major surgery within 30 days following the index procedure.
  • 5. Subject with planned treatment of lesion involving aorto-ostial location.
  • 6. Subject with planned PCI of a non-target vessel within 30 days following the index procedure.
  • 7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
  • 8. Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).
  • 9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.
  • 10. Subjects with current documented left ventricular ejection fraction (LVEF) \< 30%.
  • 11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.
  • 12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
  • 13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.A. Med Alliance S.A.,

Ron Waksman, MD, PRINCIPAL_INVESTIGATOR, Medstar Washington Hospital Center

Study Record Dates

2029-08