Back to resultsPROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
Primary Purpose
Critical Limb Ischemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LimFlow Stent Graft System
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia
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
Sites / Locations
- Medstar Washington Hospital Center
- Kaiser Permanente
- Metro Health, University of Michigan
- New Mexico Heart Institute
- Mount Sinai Health System
- University Hospitals Cleveland Medical Center
- Palmetto Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Treated with the LimFlow Stent Graft System
Outcomes
Primary Outcome Measures
Amputation-free survival
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Secondary Outcome Measures
Amputation-free survival
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
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.
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.
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.
Limb Salvage
Percentage of subjects with freedom from above-ankle amputation of the index limb
Wound Healing
Percentage of subjects with completed index wound healing
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03124875
Brief Title
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
January 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LimFlow, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multi-center pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treated with the LimFlow Stent Graft System
Intervention Type
Device
Intervention Name(s)
LimFlow Stent Graft System
Intervention Description
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
Primary Outcome Measure Information:
Title
Amputation-free survival
Description
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Time Frame
30 days post-procedure
Secondary Outcome Measure Information:
Title
Amputation-free survival
Description
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Time Frame
6 months post-procedure
Title
Primary Patency
Description
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.
Time Frame
30 days post-procedure
Title
Primary Patency
Description
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.
Time Frame
6 months post-procedure
Title
Secondary Patency
Description
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.
Time Frame
6 months post-procedure
Title
Limb Salvage
Description
Percentage of subjects with freedom from above-ankle amputation of the index limb
Time Frame
3, 6, 9, and 12 months post-procedure
Title
Wound Healing
Description
Percentage of subjects with completed index wound healing
Time Frame
3, 6, 9, and 12 months post-procedure
Title
Deterioration in Renal Function
Description
Percentage of subjects with a 25% increase in serum creatinine after using iodine contrast agents, without another clear cause for kidney injury.
Time Frame
6 months post-procedure
Title
Technical Success
Description
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.
Time Frame
Post-procedure
Title
Procedural Success
Description
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.
Time Frame
30 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihad Mustapha, MD
Organizational Affiliation
Metro Health, University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Kaiser Permanente
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Metro Health, University of Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Mount Sinai Health System
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Palmetto Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
We'll reach out to this number within 24 hrs