SELUTION4BTK Trial

Part of paid clinical trials in Chandler, Arizona.

Sponsor
M.A. Med Alliance S.A.
Study ID
NCT05055297
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SELUTION SLR™ DEB 014 — DEVICE
    a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia
  • Plain (Uncoated) Balloon Angioplasty (PTA) — DEVICE
    a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

Study Details

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

Key Dates

Start date
May 19, 2022
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Jul 30, 2032

Study Design

Enrollment
376 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SELUTION SLR™ DEB 014
  • Active Comparator: Plain (Uncoated) Balloon Angioplasty (PTA)

Primary Outcome Measure

Primary Efficacy Endpoint [ Time Frame: 6 months ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Chandler Regional Medical CenterChandlerArizona85297
MedAlliance Clinical Team
[email protected]
Dan Sraow, MD (PRINCIPAL_INVESTIGATOR)
St. Bernards Medical CenterJonesboroArkansas72401
MedAlliance Clinical Team
[email protected]
Maximiliano Arroyo, MD (PRINCIPAL_INVESTIGATOR)
Arkansas Heart HospitalLittle RockArkansas72211-
St. Helena HospitalSt. HelenaCalifornia94574-
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterTorranceCalifornia90502
MedAlliance Clinical Team
[email protected]
Nikhil Kansal, MD (PRINCIPAL_INVESTIGATOR)
ClinRéThorntonColorado80023-
Vascular Care GroupDarienConnecticut06820
MedAlliance Clinical Team
[email protected]
Edward Arous, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06519
MedAlliance Clinical Team
[email protected]
Carlos Mena, MD (PRINCIPAL_INVESTIGATOR)
The Cardiac and Vascular Institute Research FoundationGainesvilleFlorida32605
MedAlliance Clinical Team
[email protected]
Arthur Lee, MD (PRINCIPAL_INVESTIGATOR)
Palm Vascular CentersMiamiFlorida33141
MedAlliance Clinical Team
[email protected]
Robert Beasley, MD (PRINCIPAL_INVESTIGATOR)
Guardian Research Organization, LLCWinter ParkFlorida32792
MedAlliance Clinical Team
[email protected]
Ashish Gupta, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Consultants of South GeorgiaThomasvilleGeorgia31792-
Rush University Medical CenterChicagoIllinois60612
MedAlliance Clinical Team
[email protected]
Sreekumar Madassery, MD (PRINCIPAL_INVESTIGATOR)
Advocate Lutheran General HospitalPark RidgeIllinois60068
MedAlliance Clinical Team
[email protected]
Lewis Schwartz, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Institute of the SouthGrayLouisiana70359
MedAlliance Clinical Team
[email protected]
Craig Walker, MD (PRINCIPAL_INVESTIGATOR)
MedStar Health Research InstituteHyattsvilleMaryland20782
MedAlliance Clinical Team
[email protected]
Nelson Bernardo, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Medical CenterBostonMassachusetts02215
MedAlliance Clinical Team
[email protected]
Mark Wyers, MD (PRINCIPAL_INVESTIGATOR)
University of Massachusetts Medical CenterWorcesterMassachusetts01655
MedAlliance Clinical Team
[email protected]
Douglas Jones, MD (PRINCIPAL_INVESTIGATOR)
Sorin Medical GroupNew YorkNew York10005
MedAlliance Clinical Team
[email protected]
Justin Ratcliffe, MD (PRINCIPAL_INVESTIGATOR)
NC Heart and Vascular Research, LLCRaleighNorth Carolina27607
MedAlliance Clinical Team
[email protected]
Mohit Pasi, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
MedAlliance Clinical Team
[email protected]
Ali Khalifeh, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
MedAlliance Clinical Study Team
[email protected]
Mehdi Shishehbor, MD (PRINCIPAL_INVESTIGATOR)
Hightower Clinical ResearchOklahoma CityOklahoma73134
MedAlliance Clinical Study Team
[email protected]
Jim Melton, MD (PRINCIPAL_INVESTIGATOR)
Miriam HospitalProvidenceRhode Island02906
MedAlliance Clinical Team
[email protected]
Peter Soukas, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
MedAlliance Clinical Team
[email protected]
Daniel Clair, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Center for Clinical TrialsTullahomaTennessee37388-
El Paso CardiologyEl PasoTexas79912
MedAlliance Clinical Team
[email protected]
Laiq Raja, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
MedAlliance Clinical Team
[email protected]
Jayer Chung, MD (PRINCIPAL_INVESTIGATOR)
Texas Cardiac and Vascular Institute San AntonioSan AntonioTexas78229
MedAlliance Clinical Team
[email protected]
Jason Yoho, MD (PRINCIPAL_INVESTIGATOR)
Christus HealthTylerTexas75702
MedAlliance Clinical Team
[email protected]
Jeff Carr, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chandler, AZ

By research site
Chandler Regional Medical Center· Chandler, AZSt. Bernards Medical Center· Jonesboro, ARArkansas Heart Hospital· Little Rock, ARSt. Helena Hospital· St. Helena, CALundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center· Torrance, CAClinRé· Thornton, CO

Related Studies