Below-the-Knee Interventions for Limb Salvage

This study is looking at different ways to treat blocked arteries below the knee in people with Peripheral Arterial Disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs. Specifically, it focuses on patients with severe PAD (Rutherford 4 and 5) who might benefit from improved blood flow. The study compares a new device called the Finesse BTK Multicath® with standard treatments that use regular angioplasty balloon catheters. Researchers want to see if the Finesse BTK Multicath® helps reduce the amount of contrast dye used during the procedure. You may be able to join if you are 18 or older and need a procedure to open blocked arteries in your lower leg.

Study design: This is a non-randomized registry study, meaning participants are not randomly assigned to a treatment. It plans to enroll 24 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome, contrast volume, is measured during the intervention/procedure/surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters

Not Yet Recruiting

NAAges 18+InterventionalTreatment

Summa Therapeutics, LLC

~24 participants

Updated 2025-04-02 on ClinicalTrials.gov

What's tested:MulticathStandard of Care (SOC)

At a glance

Recruiting sites

0 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Contrast volume

Measured over during the intervention/procedure/surgery

Conditions

Peripheral Arterial Disease Below the Knee

Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization

Where it's being run

2 sites across 2 states

Delaware1

New Jersey1

Who to contact

Timothy Murphy, M.D.

[email protected]

8772672685

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Participant must provide written informed consent prior to any clinical investigation-related procedures.

Age ≥ 18 years

Planned lower extremity catheter-based revascularization for Rutherford 4 through 6 chronic limb-threatening ischemia (Table 1)

Stenotic (\>=70% stenosis by visual estimate) or occlusive lesion in an infrapopliteal artery (anterior tibial, peroneal, or posterior tibial) by angiography

Target lesion up to 25cm in length by angiography

Exclusion

Participation in another clinical investigation that has not yet completed its primary end point.

Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.

Female subjects of childbearing potential unless negative pregnancy test or contraceptive use

Bilateral critical limb ischemia

Planned bilateral vascular intervention

Lack of reconstitution of foot runoff vessels at ankle joint

Planned below-the-ankle intervention after completion of diagnostic angiography

Planned suprainguinal intervention -\>=5cm with at least 50% stenosis of the above knee femoro-popliteal artery

What this trial measures

Contrast volumeduring the intervention/procedure/surgery

Trialytics