PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

NCT03124875 | Completed Results DMC FDA Device

• 1 other identifier: ECO-02527-009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 7

Brief Summary

This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Conditions

Critical Limb Ischemia; Chronic Limb-Threatening Ischemia

Keywords

Transcatheter Arterialization of Deep Veins; Percutaneous Deep Vein Arterialization; LimFlow System

Outcome Measures

Primary Outcomes (1)

• Amputation-free Survival

  Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

  30 days post-procedure

Secondary Outcomes (9)

• Amputation-free Survival

  6 months post-procedure

• Primary Patency

  30 days post-procedure

• Primary Patency

  6 months post-procedure

• Secondary Patency

  6 months post-procedure

• Limb Salvage

  12 months post-procedure

Study Arms (1)

Treatment

EXPERIMENTAL

Treated with the LimFlow System

Device: LimFlow System

Interventions

LimFlow System DEVICE

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

Treatment

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of critical limb ischemia with hemodynamic evidence of severely diminished arterial inflow of the index limb and Rutherford Classification 5 r 6
• Reviewed and approved for eligibility by the Investigator and the Independent Safety Committee (ISC)

You may not qualify if:

• Concomitant hepatic or renal insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder
• Severe heart failure, recent MI or stroke
• Significant peripheral edema or infection that may preclude insertion of a prosthesis or significantly impair wound healing
• Known allergies or contraindications to anti platelet therapy or device materials
• Immunodeficiency disorder or immunosuppressant therapy
• Life expectancy \< 12 months

Sponsors & Collaborators

• LimFlow, Inc.: lead

Study Sites (7)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Kaiser Permanente

Honolulu, Hawaii, 96817, United States

Location

Metro Health, University of Michigan

Wyoming, Michigan, 49519, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Palmetto Health

Columbia, South Carolina, 29203, United States

Location

Related Publications (2)

• Mustapha JA, Saab FA, Clair D, Schneider P. Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia. J Invasive Cardiol. 2019 Mar;31(3):57-63. doi: 10.25270/jic/18.00340.

  PMID: 30819976 RESULT

• Clair DG, Mustapha JA, Shishehbor MH, Schneider PA, Henao S, Bernardo NN, Deaton DH. PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results. J Vasc Surg. 2021 Nov;74(5):1626-1635. doi: 10.1016/j.jvs.2021.04.057. Epub 2021 May 18.

  PMID: 34019990 RESULT

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Results Point of Contact

• Title: Cecilia Petrella
• Organization: LimFlow Inc.

cpetrella@limflow.com

(888) 478-7705

Study Officials

• Jihad Mustapha, MD

  Metro Health, University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center pilot study

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: July 5, 2017
• Primary Completion: August 8, 2019
• Study Completion: January 5, 2021
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)