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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
Must not have
Active infection (e.g., fever, significantly elevated WBC count >20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals)
Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have severe leg circulation problems with ulcers or gangrene.
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I cannot have standard surgery to save my limb because of specific artery and vein issues.
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I am between 18 and 95 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an active infection that could interfere with surgery.
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I have an active immune disorder or am on immunosuppressant therapy.
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I am allergic to aspirin, certain heart medications, heparin, stainless steel, nitinol, or contrast dyes and cannot be treated for these allergies.
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I had a surgery to improve blood flow in my leg that might affect a new graft.
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My target foot lacks enough healthy tissue.
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My kidney function is poor, with a creatinine level over 2.5 mg/dl, and I am not on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amputation Free Survival
Secondary study objectives
All Wound Area Reduction
All Wound Healing
Change in Rutherford Classification
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treated with LimFlowExperimental Treatment1 Intervention
Treatment with the LimFlow Stent Graft System

Find a Location

Who is running the clinical trial?

LimFlow, Inc.Lead Sponsor
3 Previous Clinical Trials
337 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
305 Patients Enrolled for Peripheral Arterial Disease
Daniel Clair, MDPrincipal InvestigatorVanderbilt University
4 Previous Clinical Trials
687 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
238 Patients Enrolled for Peripheral Arterial Disease
Mehdi ShishehborPrincipal InvestigatorUniversity Hospital Cleveland
2 Previous Clinical Trials
105 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
105 Patients Enrolled for Peripheral Arterial Disease

Media Library

LimFlow Stent Graft System (Stent Graft System) Clinical Trial Eligibility Overview. Trial Name: NCT05313165 — N/A
Peripheral Arterial Disease Research Study Groups: Treated with LimFlow
Peripheral Arterial Disease Clinical Trial 2023: LimFlow Stent Graft System Highlights & Side Effects. Trial Name: NCT05313165 — N/A
LimFlow Stent Graft System (Stent Graft System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05313165 — N/A
~56 spots leftby May 2027
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