RECRUITING

SELUTION 4 De Novo Small Vessel IDE Trial

Conditions

Coronary Artery Disease CAD DCB DEB NSTEMI Stable Angina Chronic Coronary Syndrome CCS Drug Coated Balloons Drug Eluting Balloons Small Vessels SELUTIONSLR Sirolimus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-20

Study Completion:2029-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05946629

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Rebecca Apruzzese

CONTACT

2016001527

rebecca.apruzzese@cordis.com

Susanne Meis

CONTACT

+491718918919

susanne.meis@cordis.com

Principal Investigator

Ron Waksman, MD

PRINCIPAL_INVESTIGATOR

Medstar Washington Hospital Center

Study Locations (Sites)

HCA Los Robles

Thousand Oaks, California, 91360

United States

Harbor UCLA

Torrance, California, 90502

United States

Colorado Heart and Vascular

Golden, Colorado, 80401

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

HCA Florida JFK

Atlantis, Florida, 33462

United States

Mease Countryside Hospital

Clearwater, Florida, 34695

United States

University of Florida, Jacksonville

Jacksonville, Florida, 32209

United States

HCA Largo

Largo, Florida, 33770

United States

Atlanta VA

Atlanta, Georgia, 30033

United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226

United States

Baystate Medical Center

Springfield, Massachusetts, 01199

United States

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

NC Heart and Vascular

Raleigh, North Carolina, 27607

United States

UPMC Pinnacle

Mechanicsburg, Pennsylvania, 17050

United States

HCA Centennial

Nashville, Tennessee, 37203

United States

Baylor Scott and White - Dallas

Dallas, Texas, 75246

United States

Baylor Scott and White - Temple

Temple, Texas, 76508

United States

HCA Chippenham

Richmond, Virginia, 23225

United States

Collaborators and Investigators

Sponsor: M.A. Med Alliance S.A.

Ron Waksman, MD, PRINCIPAL_INVESTIGATOR, Medstar Washington Hospital Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20

Study Completion Date2029-08

Study Record Updates

Study Start Date2023-10-20

Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

CAD
DCB
DEB
NSTEMI
Stable Angina
Chronic Coronary Syndrome
CCS
Drug Coated Balloons
Drug Eluting Balloons
Small Vessels
SELUTIONSLR
Sirolimus

Additional Relevant MeSH Terms

Coronary Artery Disease