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

NAActive, not recruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

December 6, 2019

Primary Completion Date

September 9, 2022

Study Completion Date

February 28, 2025

Conditions
Critical Limb IschemiaCritical Lower Limb IschemiaPeripheral Artery DiseasePeripheral Arterial DiseaseChronic Limb-Threatening IschemiaArterial Occlusive DiseasesArterial OcclusionArterial DiseasePeripheral Artery OcclusionPeripheral Vascular DiseasePeripheral IschemiaVascular Diseases
Interventions
DEVICE

LimFlow System

Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia

Trial Locations (21)

28203

Atrium Health, Charlotte

28401

Coastal Carolina Surgical Associates, Wilmington

29203

Prisma Health -- Midlands, Columbia

29615

Prisma Health -- Upstate, Greenville

32605

The Cardiac and Vascular Institute, Gainesville

32608

University of Florida, Gainesville

37232

Vanderbilt University Medical Center, Nashville

44106

University Hospitals Cleveland Medical Center, Cleveland

50309

Unitypoint Health, Des Moines

64086

Saint Luke's Hospital, Lee's Summit

70065

Ochsner Health System, Kenner

77030

Baylor College of Medicine, Houston

78723

Seton Heart, Austin

87102

New Mexico Heart Institute, Albuquerque

90502

Harbor-UCLA Medical Center, Torrance

94143

University of California San Francisco, San Francisco

06519

Yale University, New Haven

02114

Massachusetts General Hospital, Boston

02118

Boston Medical Center, Boston

03766

Dartmouth-Hitchcock Medical Center, Lebanon

00731

Ponce Medical School, Ponce

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LimFlow, Inc.

INDUSTRY