PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

Not Applicable

Completed

• Conditions: Critical Limb Ischemia; Chronic Limb-Threatening Ischemia
• Interventions: Device: LimFlow System

• Registration Number: NCT03124875
• Lead Sponsor: LimFlow, Inc.

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-24
• Study Start: 2017-07-05
• Primary Completion: 2019-08-08
• Study Completion: 2021-01-05
• Results First Submitted: 2023-12-20
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-16
• Last Update Submitted: 2024-05-16
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	LimFlow System	Treated with the LimFlow System

Primary Outcome Measures

Name	Time	Method
Amputation-free Survival	30 days post-procedure	Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Wound Healing	12 months post-procedure	Percentage of subjects with full wound healing
Amputation-free Survival	6 months post-procedure	Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Secondary Patency	6 months post-procedure	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.
Technical Success	Post-procedure, immediately	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.
Procedural Success	30 days post-procedure	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.
Primary Patency	6 months post-procedure	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.
Limb Salvage	12 months post-procedure	Percentage of subjects with freedom from above-ankle amputation of the index limb
Deterioration in Renal Function	6 months post-procedure	Percentage of subjects with a 25% increase in serum creatinine after using iodine contrast agents, without another clear cause for kidney injury.

Trial Locations

Locations (7)

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Metro Health, University of Michigan; 🇺🇸 Wyoming, Michigan, United States

Mount Sinai Health System; 🇺🇸 New York, New York, United States

New Mexico Heart Institute; 🇺🇸 Albuquerque, New Mexico, United States

Palmetto Health; 🇺🇸 Columbia, South Carolina, United States

Kaiser Permanente; 🇺🇸 Honolulu, Hawaii, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States