PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

Study Overview
=================
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.

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

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Device: LimFlow Stent Graft System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-center pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treated with the LimFlow Stent Graft System | Device: LimFlow Stent Graft System<br>* Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.<br>|

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 |