ACTIVE_NOT_RECRUITING

SELUTION4SFA Trial

Conditions

Peripheral Arterial Disease Superficial Femoral Artery Stenosis

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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

This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Official Title

A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR™ 018 Drug Eluting Balloon in the Treatment of Subjects With Femoropopliteal Artery Lesions

Quick Facts

Study Start:2022-12-01

Study Completion:2030-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05132361

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
1. Subject age is ≥ 18 years or minimum legal age as required by local regulations. 2. Life expectancy \>1 year in opinion of investigator. 3. Documented ischemia with Rutherford classification category 2, 3 or 4. 4. Target lesion(s) in the SFA or PPA. 5. Able to walk without the assistance of a walker. 6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. 7. Female subjects only: If female, then subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure and be prepared to use effective contraception for 12 months after treatment.	1. Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with exception for diagnostic angiography. 2. Inability to tolerate dual antiplatelet therapy. 3. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent, which are required for the procedure and which cannot be adequately pre-treated. 4. Stroke or MI within 3 months of enrollment. 5. Symptom onset less than 14 days prior to index procedure (acute limb ischemia). 6. Lower limb disease in the contralateral leg that requires treatment at the index procedure, or, that is planned within 14 days prior to the index procedure or within 30 days after the index procedure. 7. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb. 8. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease) 9. Target lesion requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured balloon, stenting, laser, cryoplasty, intravascular lithotripsy, brachytherapy, re-entry device). 10. Subject has target lesion(s) that require treatment via pedal site. 11. Subject has target lesion(s) that require access via upper extremity arteries. 12. Hypercoagulable state or disorder present, or coagulopathy present, including platelet count less than 80,000 per microliter. 13. Chronic renal insufficiency (dialysis dependent, or serum creatinine \>2.5 mg/dL within 30 days of index procedure). 14. Systemic infection (WBC \> 12,000 and febrile) or known immune compromise. 15. Breast-feeding woman. 16. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.

Inclusion Criteria

Exclusion Criteria

1. Subject age is ≥ 18 years or minimum legal age as required by local regulations.
2. Life expectancy \>1 year in opinion of investigator.
3. Documented ischemia with Rutherford classification category 2, 3 or 4.
4. Target lesion(s) in the SFA or PPA.
5. Able to walk without the assistance of a walker.
6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
7. Female subjects only: If female, then subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure and be prepared to use effective contraception for 12 months after treatment.

1. Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with exception for diagnostic angiography.
2. Inability to tolerate dual antiplatelet therapy.
3. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent, which are required for the procedure and which cannot be adequately pre-treated.
4. Stroke or MI within 3 months of enrollment.
5. Symptom onset less than 14 days prior to index procedure (acute limb ischemia).
6. Lower limb disease in the contralateral leg that requires treatment at the index procedure, or, that is planned within 14 days prior to the index procedure or within 30 days after the index procedure.
7. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb.
8. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease)
9. Target lesion requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured balloon, stenting, laser, cryoplasty, intravascular lithotripsy, brachytherapy, re-entry device).
10. Subject has target lesion(s) that require treatment via pedal site.
11. Subject has target lesion(s) that require access via upper extremity arteries.
12. Hypercoagulable state or disorder present, or coagulopathy present, including platelet count less than 80,000 per microliter.
13. Chronic renal insufficiency (dialysis dependent, or serum creatinine \>2.5 mg/dL within 30 days of index procedure).
14. Systemic infection (WBC \> 12,000 and febrile) or known immune compromise.
15. Breast-feeding woman.
16. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.

Contacts and Locations

Study Locations (Sites)

St. Bernards Medical Center

Jonesboro, Arkansas, 72401

United States

Arkansas Heart Hospital

Little Rock, Arkansas, 72211

United States

Mission Cardiovascular Research Institute

Fremont, California, 94538

United States

St. Helena Hospital

Saint Helena, California, 94558

United States

ClinRé

Thornton, Colorado, 80023

United States

Vascular Care Group

Darien, Connecticut, 06820

United States

Yale University

New Haven, Connecticut, 06519

United States

Manatee Memorial Hospital

Bradenton, Florida, 34205

United States

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605

United States

Memorial Healthcare System

Hollywood, Florida, 33021

United States

First Coast Cardiovascular Institute

Jacksonville, Florida, 32218

United States

Palm Vascular Centers

Miami Beach, Florida, 33140

United States

Guardian Research Organization, LLC

Winter Park, Florida, 32792

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, 31792

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Heart Care Centers Research Foundation

Palos Park, Illinois, 60464

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Cardiovascular Institute of the South

Gray, Louisiana, 70359

United States

MedStar Health Research Institute

Hyattsville, Maryland, 20782

United States

Mercy Hospital

Saint Louis, Missouri, 63128

United States

Holy Name Medical Center

Teaneck, New Jersey, 07666

United States

James J. Peters VA Medical Center

Bronx, New York, 10468

United States

Mount Sinai

New York, New York, 11766

United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

OhioHealth Riverside Hospital

Columbus, Ohio, 43214

United States

Miriam Hospital

Providence, Rhode Island, 02906

United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, 37388

United States

El Paso Cardiology

El Paso, Texas, 79902

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Heart Hospital Baylor Plano

Plano, Texas, 75093

United States

Texas Cardiac and Vascular Institute San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

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

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 Date2022-12-01

Study Completion Date2030-12-01

Study Record Updates

Study Start Date2022-12-01

Study Completion Date2030-12-01

Terms related to this study

Additional Relevant MeSH Terms

Peripheral Arterial Disease
Superficial Femoral Artery Stenosis