What side effects are associated with this type of intervention?

Endovascular revascularization treatments for Arterial Occlusive Disease, such as angioplasty and stenting, can lead to side effects including bleeding, infection, vessel damage, and restenosis. The use of drug-coated devices, like paclitaxel-coated balloons or stents, has raised safety concerns, including potential increased mortality risks. Other side effects may include allergic reactions to contrast dye and anesthesia-related complications.

What prior FDA approvals exist?

FDA-approved treatments for arterial occlusive disease include various endovascular revascularization techniques such as percutaneous transluminal angioplasty (PTA), drug-coated balloons (DCBs), and stents. Drug-eluting stents, which release medication to prevent restenosis, have also been approved. These treatments aim to restore blood flow and are similar to the LimFlow System, which is designed for patients with chronic limb-threatening ischemia who have no other surgical or endovascular options.

What other types of research exist?

Promising novel alternatives to the LimFlow System for treating arterial occlusive disease in patients with chronic limb-threatening ischemia include: 1) Excimer Laser Ablation, which has shown sustained efficacy in plaque recanalization for diabetic patients with critical limb ischemia. 2) Transarterial Radioembolization (TARE) using yttrium-90 microspheres, particularly for cases complicated by malignant portal vein thrombus. 3) Supervised Exercise Therapy combined with endovascular revascularization, which has demonstrated improvements in walking performance and physical capacity in patients with peripheral artery disease.

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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.

Must not have

Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder

Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in subjects not undergoing dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates the safety and effectiveness of the LimFlow System, a device that helps improve leg blood flow in patients with severe blood flow issues who can't be treated with usual treatments. It works by creating a new artery-to-vein connection below the knee to enhance circulation.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 95 years old.

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I cannot have standard surgery to save my limb due to specific artery and vein conditions.

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I have severe leg circulation problems, with ulcers or gangrene.

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I have been diagnosed with severe blood flow problems in my limb.

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I have severe leg pain due to poor blood flow, with ulcers or gangrene.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active immune disorder or am on immunosuppressant therapy.

Select...

My kidney function is impaired with a creatinine level over 2.5 mg/dl, and I am not on dialysis.

Select...

I do not have severe leg blood vessel problems that could affect surgery or healing.

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I have had a major amputation or have a wound needing advanced skin grafting.

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I am allergic to aspirin, certain heart medications, heparin, stainless steel, nitinol, or contrast dyes.

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I haven't had liver problems, vein inflammation in the limb, or blood clotting issues in the last 3 months.

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I do not have an active infection that could interfere with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-procedure 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 (AFS)

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: Treatment ArmExperimental Treatment1 Intervention

Treated with the LimFlow System

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LimFlow System

2017

N/A

~40

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Arterial Occlusive Disease, especially in patients with chronic limb-threatening ischemia (CLTI), include endovascular revascularization techniques such as angioplasty, stenting, and the LimFlow System. Angioplasty involves inflating a balloon within the artery to widen it and improve blood flow. Stenting places a mesh tube to keep the artery open. The LimFlow System, a newer technique, creates a bypass within the vein to restore blood flow to the foot when no other options are viable. These treatments are crucial as they aim to restore adequate blood flow, alleviate ischemic pain, and prevent limb loss, significantly improving the quality of life for patients with severe arterial occlusions.

Excimer laser assisted angioplasty for the treatment of critical limb ischemia.