PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

Critical Limb Ischemia Clinical Trial

Official title:

Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124875
• Other study ID #: ECO-02527-009
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia

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