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Stent Graft System
LimFlow Stent Graft System for Critical Limb Ischemia
N/A
Recruiting
Led By Daniel Clair, MD
Research Sponsored by LimFlow, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and Rutherford Classification 5, ischemic ulceration or Rutherford Classification 6, ischemic gangrene
Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will study how a medical device helps patients with leg artery blockages.
Who is the study for?
This trial is for adults aged 18-95 with severe chronic limb-threatening ischemia, classified as Rutherford 5 or 6, where traditional treatments are not feasible. Candidates must have stable wounds and blood sugar levels (HbA1C <10%), be non-pregnant if of childbearing potential, and able to consent. Exclusions include recent heart attack or stroke, certain kidney diseases, inability to follow the study protocol, severe heart failure, other medical conditions that could interfere with participation, life expectancy under a year, allergies to specific medications or materials used in the procedure.Check my eligibility
What is being tested?
The LimFlow Stent Graft System is being tested in this single-arm study across multiple centers. The device aims to create new pathways for blood flow in patients whose limbs are at risk due to poor circulation from peripheral arterial disease.See study design
What are the potential side effects?
Potential side effects may include local complications at the site of stent graft placement such as infection or bleeding; allergic reactions to materials like stainless steel or nitinol; contrast agent reactions; and general risks associated with percutaneous procedures like bruising or clotting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe leg circulation problems with ulcers or gangrene.
Select...
I cannot have standard surgery to save my limb because of specific artery and vein issues.
Select...
I am between 18 and 95 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amputation Free Survival
Secondary outcome measures
All Wound Area Reduction
All Wound Healing
Change in Rutherford Classification
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treated with LimFlowExperimental Treatment1 Intervention
Treatment with the LimFlow Stent Graft System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LimFlow Stent Graft System
2017
N/A
~40
Find a Location
Who is running the clinical trial?
LimFlow, Inc.Lead Sponsor
3 Previous Clinical Trials
337 Total Patients Enrolled
Daniel Clair, MDPrincipal InvestigatorVanderbilt University
4 Previous Clinical Trials
687 Total Patients Enrolled
Mehdi ShishehborPrincipal InvestigatorUniversity Hospital Cleveland
2 Previous Clinical Trials
105 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe leg circulation problems with ulcers or gangrene.Your blood sugar levels are well controlled, with a HbA1C level of less than 10%.The blood vessel near the cross-over point needs to be the right size for the LimFlow stent graft.I am on blood thinners that may affect my safety in the study.I have severe heart failure that might make surgery risky.I do not have an active infection that could interfere with surgery.I have an active immune disorder or am on immunosuppressant therapy.I am allergic to aspirin, certain heart medications, heparin, stainless steel, nitinol, or contrast dyes and cannot be treated for these allergies.I do not have severe leg blood vessel problems that could affect surgery healing.I cannot have standard surgery to save my limb because of specific artery and vein issues.I have been on dialysis for over 6 months, use an AV fistula or peritoneal access, and meet the specified health criteria.I had a surgery to improve blood flow in my leg that might affect a new graft.My target foot lacks enough healthy tissue.The blood vessel where the stent will be placed needs to be the right size based on what the doctors can see.I have had a heart attack or stroke in the last 3 months.I haven't had liver problems, vein inflammation, or bleeding disorders in the last 3 months.My wound is not getting worse and shows signs of healing.My kidney function is poor, with a creatinine level over 2.5 mg/dl, and I am not on dialysis.I am between 18 and 95 years old.You are expected to live for less than a year.
Research Study Groups:
This trial has the following groups:- Group 1: Treated with LimFlow
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What qualifications must a participant meet to be accepted into this research project?
"Eligible individuals for this study should present with peripheral arterial disease and be within the ages of 18 to 95 years old. Approximately 100 participants are expected to enroll in total."
Answered by AI
Could you divulge the aggregate amount of participants in this experiment?
"To complete this study, 100 eligible participants must be enrolled. For their convenience, individuals can join at one of the two clinical sites: University of Florida in Boston, Massachusetts or Massachusetts General Hospital in Lebanon, New hampshire."
Answered by AI
Is enrollment open to elderly individuals in this experiment?
"This clinical trial requires patients to be a minimum of 18 years old and no older than 95 if they wish to qualify for inclusion."
Answered by AI
What is the number of medical facilities currently assessing this trial?
"The University of Florida in Boston, Massachusetts General Hospital in Lebanon, New hampshire and Dartmouth-Hitchcock Medical Center in Cleveland, Ohio are a few amongst the 5 clinical trial sites hosting this research."
Answered by AI
Is enrollment for this research project still open?
"Affirmative. Clinicaltrials.gov data reveals that this trial is actively enrolling participants, as it was first posted on December 22nd 2022 and updated most recently on April 14th 2023. One hundred individuals will be recruited from 5 distinct sites."
Answered by AI
Who else is applying?
What site did they apply to?
University Hospitals Cleveland Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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