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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03124875
Other study ID # ECO-02527-009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2017
Est. completion date January 5, 2021

Study information

Verified date May 2024
Source LimFlow, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The PROMISE I Trial was a prospective, multi-center, single-arm, investigational feasibility study assessing the LimFlow System for the treatment of chronic- limb-threatening ischemia by creating an arterio-venous fistula in the below-the-knee vasculature. The study was run under an investigational device exemption (IDE G160156, NCT03124875). Thirty-two subjects were enrolled under protocol revisions A, B, C, and D at seven sites in the United States between 5-July-2017 and 8-April-2019.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 5, 2021
Est. primary completion date August 8, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 95 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States New Mexico Heart Institute Albuquerque New Mexico
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Palmetto Health Columbia South Carolina
United States Kaiser Permanente Honolulu Hawaii
United States Mount Sinai Health System New York New York
United States Medstar Washington Hospital Center Washington District of Columbia
United States Metro Health, University of Michigan Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
LimFlow, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Va — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Amputation-free Survival Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality 6 months post-procedure
Secondary Primary Patency Percentage of patients with absence of total occlusion of the stent graft without prior clinically-driven major re-intervention of the stent graft. Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft. 30 days post-procedure
Secondary Primary Patency Percentage of patients with absence of total occlusion of the stent graft without prior clinically-driven major re-intervention of the stent graft.Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft. 6 months post-procedure
Secondary Secondary Patency Percentage of patients with absence of total occlusion of the stent graft with or without prior clinically-driven major re-intervention of the stent graft.Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft. 6 months post-procedure
Secondary Limb Salvage Percentage of subjects with freedom from above-ankle amputation of the index limb 12 months post-procedure
Secondary Wound Healing Percentage of subjects with full wound healing 12 months post-procedure
Secondary Deterioration in Renal Function Percentage of subjects with a 25% increase in serum creatinine after using iodine contrast agents, without another clear cause for kidney injury. 6 months post-procedure
Secondary Technical Success Percentage of subjects with completion of the endovascular procedure and immediate morphological success with successful placement of the arterial and venous catheters in the desired location in the limb, and ability to place the stent graft. Post-procedure, immediately
Secondary Procedural Success Percentage of subjects with a combination of Technical Success and absence of all-cause mortality, above-ankle amputation or clinically driven major re-intervention of the stent graft. 30 days post-procedure
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