Pivotal Trial of the Boomerang Catheter for pDVA

Part of paid clinical trials in San Bernardino, California.

Sponsor
Aveera Medical, Inc.
Study ID
NCT06311773
Status
Enrolling By Invitation

Conditions

  • Chronic Limb-Threatening Ischemia

Eligibility Criteria

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

Interventions

  • Boomerang Catheter — DEVICE
    The study device used for this procedure makes an anastomosis between a tibial vein and a tibial artery to direct blood flow around blocked arteries.

Study Details

The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.

Key Dates

First listed
Mar 15, 2024
Start date
Apr 16, 2024
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treated with Boomerang Catheter

Primary Outcome Measure

Amputation Free Survival (AFS) [ Time Frame: 6-months ]

Locations (25)

FacilityCityStateZIPSite coordinators
Arrowhead Regional Medical CenterSan BernardinoCalifornia92324-
Olive View-UCLA Medical CenterSylmarCalifornia91342-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-
PIH Whittier HospitalWhittierCalifornia90602-
EndoVascular ConsultantsWilmingtonDelaware19805-
First Coast Cardiovascular InstituteJacksonvilleFlorida32256-
Rush University Medical CenterChicagoIllinois60612-
Cardiovascular Institute of the SouthHoumaLouisiana70360-
Massachusetts General HospitalBostonMassachusetts02114-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Vascular Institute at AMIGallowayNew Jersey08205-
American Endovascular and Amputation PreventionWest OrangeNew Jersey07052-
Northwell Health - Lake SuccessLake SuccessNew York11042-
Weill Cornell Medical CenterNew YorkNew York10065-
Sunrise VascularMurphyNorth Carolina28906-
Advanced Vascular CentersTigardOregon97223-
St. Luke's University HospitalBethlehemPennsylvania18015-
Penn MedicinePhiladelphiaPennsylvania19104-
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
VIC Vascular InstituteChattanoogaTennessee37421-
Vanderbilt University Medical CenterNashvilleTennessee37232-
UT Southwestern Medical CenterDallasTexas75235-
Baylor College of MedicineHoustonTexas77030-
HOPE Vascular and PodiatryHoustonTexas77054-
University of Washington MedicineSeattleWashington98133-

Find similar trials in San Bernardino, CA

By research site
Arrowhead Regional Medical Center· San Bernardino, CAOlive View-UCLA Medical Center· Sylmar, CALundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center· Torrance, CAPIH Whittier Hospital· Whittier, CAEndoVascular Consultants· Wilmington, DEFirst Coast Cardiovascular Institute· Jacksonville, FL

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