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Device
LimFlow System for Critical Limb Ischemia (PROMISE Trial)
N/A
Waitlist Available
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
Subject must be ≥18 and ≤ 95 years of age
Subject has been assessed by the principal investigator, reviewed by the Independent Review Committee (IRC), 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 post-procedure
Awards & highlights
PROMISE Trial Summary
This trial is for a new minimally invasive treatment for patients with no other options for chronic limb-threatening ischemia.
Who is the study for?
The PROMISE II trial is for adults aged 18-95 with chronic limb-threatening ischemia who have no other surgical or endovascular options available. Candidates should be part of a wound care network, able to follow medication and visit schedules, not pregnant if of childbearing potential, and may include those on dialysis with stable conditions.Check my eligibility
What is being tested?
This trial tests the LimFlow System, which is a minimally invasive procedure designed for patients with severe arterial blockages in their limbs that cannot be treated by traditional surgeries or therapies.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include infection at the access site, bleeding, blood vessel damage from catheter insertion, allergic reactions to materials used in the LimFlow System or contrast agents during imaging.
PROMISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 95 years old.
Select...
I cannot have standard surgery to save my limb due to specific artery and vein conditions.
Select...
I have severe leg circulation problems, with ulcers or gangrene.
Select...
I have been diagnosed with severe blood flow problems in my limb.
Select...
I have severe leg pain due to poor blood flow, with ulcers or gangrene.
PROMISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-procedure
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 (AFS)
Secondary outcome measures
All Wound Area Reduction
All Wound Healing
Change in Rutherford Classification
+11 morePROMISE Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Treated with the LimFlow System
Find a Location
Who is running the clinical trial?
LimFlow, Inc.Lead Sponsor
3 Previous Clinical Trials
332 Total Patients Enrolled
Daniel Clair, MDPrincipal InvestigatorVanderbilt University
4 Previous Clinical Trials
682 Total Patients Enrolled
Mehdi ShishehborPrincipal InvestigatorUniversity Hospital Cleveland
2 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a childbearing potential womanI am scheduled for a minor amputation on my foot or toe within 30 days after a procedure.I am between 18 and 95 years old.I have been on dialysis for more than 6 months, use an AV fistula or peritoneal access, and meet the specified health criteria.I have an active immune disorder or am on immunosuppressant therapy.I cannot have standard surgery or procedures to save my limb due to specific artery and vein conditions.I cannot have standard surgery to save my limb due to specific artery and vein conditions.You are allowed to have had stents placed in the arteries below your groin.I have severe heart failure that might make surgery risky.You are allowed to have had stents placed in certain leg arteries before.My kidney function is impaired with a creatinine level over 2.5 mg/dl, and I am not on dialysis.The artery for my LimFlow procedure is the right size.I do not have severe leg blood vessel problems that could affect surgery or healing.I have had a major amputation or have a wound needing advanced skin grafting.I am scheduled for a minor foot or toe amputation soon after my main treatment.I am on blood thinners that may affect my participation in the study.Your blood sugar levels are well managed, with HbA1C less than 10%.I have severe leg circulation problems, with ulcers or gangrene.I have been diagnosed with severe blood flow problems in my limb.I am allergic to aspirin, certain heart medications, heparin, stainless steel, nitinol, or contrast dyes.You are expected to live for less than 12 months.My wound is not getting worse and shows signs of healing.I haven't had liver problems, vein inflammation in the limb, or blood clotting issues in the last 3 months.I have had a heart attack or stroke in the last 3 months.I had a surgery to improve blood flow in my leg that might affect a new graft.I do not have an active infection that could interfere with surgery.The artery near the treatment area must be the right size for the stent graft.I have severe leg pain due to poor blood flow, with ulcers or gangrene.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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.
Is this study actively seeking participants?
"Clinicaltrials.gov indicates that this particular trial is no longer looking for participants, as its original posting date was on December 6th 2019 and it has not been modified since November 9th 2022. However, there are currently 688 other studies recruiting patients at the present time."
Answered by AI
How many facilities are being utilized to conduct this experiment?
"This intercontinental trial is being conducted at Boston Medical Center in Massachusetts, Ochsner Health System in Louisiana and University Hospitals Cleveland Medical Centre in Ohio. Additionally, 20 other medical sites are participating as well."
Answered by AI
Does this trial offer participation to individuals younger than 70 years?
"This clinical trial is open to those aged 18 and above, with the cut-off set at 94."
Answered by AI
Are there any particular individuals who would be more likely to benefit from participating in this trial?
"This clinical trial seeks to recruit 105 individuals suffering from chronic limb threatening ischemia and between 18-94 years of age. The enrolment criteria includes but is not limited to: being ≥18 and ≤ 95 years old, having Rutherford Classification 5 or 6, an in-flow artery that falls within the recommended vessel diameter range for a LimFlow stent graft by visual estimation., prior stents are allowed, minor amputation (partial toe/ray/proximal foot) can be done 30 days after the procedure with consent from IRC etc.. Women of childbearing potential must have a negative pregnancy test before enrollment period (7 day window"
Answered by AI
Who else is applying?
What state do they live in?
Florida
Michigan
North Carolina
How old are they?
18 - 65
65+
What site did they apply to?
The Cardiac and Vascular Institute
Coastal Carolina Surgical Associates
University Hospitals Cleveland Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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