PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

Part of paid clinical trials in La Jolla, California.

Sponsor
LimFlow, Inc.
Study ID
NCT05313165
Status
Recruiting
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Conditions

  • Chronic Limb-Threatening Ischemia
  • Critical Limb Ischemia
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • LimFlow Stent Graft System — DEVICE
    Creation of an arteriovenous fistula in the desired limb location

Study Details

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Key Dates

Start date
Dec 22, 2022
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

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

Arms

  • Experimental: Treated with LimFlow
    Treatment with the LimFlow Stent Graft System

Primary Outcome Measure

Amputation Free Survival [ Time Frame: 6 Months ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
University of California, San Diego HealthLa JollaCalifornia92093-
Stanford University School of MedicinePalo AltoCalifornia94304-
UCSFSan FranciscoCalifornia94143-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-
Yale UniversityNew HavenConnecticut06519-
The Cardiac and Vascular InstituteGainesvilleFlorida32605
Marti Roberson
[email protected]
352-359-1561
Arthur Lee, MD (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32608-
Tallahassee Research InstituteTallahasseeFlorida32308-
Rush University Medical CenterChicagoIllinois60612-
Boston Medical CenterBostonMassachusetts02118-
Massachusetts General HospitalBostonMassachusetts02114
Erin McSweeney
[email protected]
617-726-2264
Anahita Dua, MD (PRINCIPAL_INVESTIGATOR)
UMass Chan Medical SchoolWorcesterMassachusetts01655-
Washington University / Barnes JewishSt LouisMissouri63110-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03766
Michelle Keyes
[email protected]
603-650-7966
Joceyln Beach, MD (PRINCIPAL_INVESTIGATOR)
Vascular Institute of Atlantic Medical ImagingPomonaNew Jersey08240-
Holy Name Medical CenterTeaneckNew Jersey07666-
Presbyterian HealthcareAlbuquerqueNew Mexico87113-
Northwell Health Long Island Jewish Medical CenterLake SuccessNew York11042
Sally Kaplan
[email protected]
516-233-3781
Yana Etkin (PRINCIPAL_INVESTIGATOR)
Cornell UniversityNew YorkNew York10065-
Mount SinaiNew YorkNew York10029-
NYU Langone HealthNew YorkNew York10016-
Atrium HealthCharlotteNorth Carolina28204-
University Hospitals Cleveland Medical CenterClevelandOhio44106
Amy McKnight
[email protected]
216-983-4896
Mehdi Shishehbor, MD (PRINCIPAL_INVESTIGATOR)
Penn State HealthHersheyPennsylvania17033-
University of PennsylvaniaPhiladelphiaPennsylvania19104
Alice Chen
[email protected]
267-521-7303
Elizabeth Genovese (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37212
Celia Nunez
[email protected]
615-322-4559
Daniel Clair (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390-
Sentara Norfolk General HospitalNorfolkVirginia23507
Sarah Havert
[email protected]
757-388-2991
David Dexter (PRINCIPAL_INVESTIGATOR)
Ascension Columbia St. Mary's HospitalMilwaukeeWisconsin53211-
The Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in La Jolla, CA

By research site
University of California, San Diego Health· La Jolla, CAStanford University School of Medicine· Palo Alto, CAUCSF· San Francisco, CALundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center· Torrance, CAYale University· New Haven, CTThe Cardiac and Vascular Institute· Gainesville, FL

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