PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Device: LimFlow Stent Graft System

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Kaiser Permanente
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health, University of Michigan
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Health System
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; Treated with the LimFlow Stent Graft System	Device: LimFlow Stent Graft System; Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 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
Limb Salvage	Percentage of subjects with freedom from above-ankle amputation of the index limb	3, 6, 9, and 12 months post-procedure
Wound Healing	Percentage of subjects with completed index wound healing	3, 6, 9, and 12 months post-procedure
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
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
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

Collaborators and Investigators

• Sponsor: LimFlow, Inc.
• Investigators: Principal Investigator: Jihad Mustapha, MD, Metro Health, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2017
• Primary Completion (ACTUAL): August 8, 2019
• Study Completion (ACTUAL): January 5, 2021

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: ECO-02527-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes