Not yet taking people in United StatesNo phase

Testing a balloon catheter for leg artery blockages below the knee

Tests the Finesse BTK Multicath balloon in adults with blocked leg arteries below the knee.

Key facts

Who runs it: Summa Therapeutics, LLC
Where: Vineland and Wilmington, United StatesSee the 2 sites
Trial code: NCT06906055
Registry title: Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Status: Not yet recruiting
People taking part: 24 people, planned
Started: 3 Apr 2025
Planned end: 30 Jun 2026
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Multicath
Standard of Care (SOC)
Record updated: 2 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe lack of blood flow in one leg (chronic limb-threatening ischemia) who are planned for a catheter procedure to open a blocked artery below the knee.

Age: 18 years or older
Sex: All sexes can join
Disease stage: Rutherford 4 through 6 chronic limb-threatening ischemia. A narrowing of 70% or more, or a blockage, in an artery below the knee (anterior tibial, peroneal or posterior tibial). The lesion is up to 25cm (9.8 in) long.

Main reasons for not taking part

Ischemia in both legs, or planned procedures on both legs
No blood flow restored in the foot arteries at the ankle joint
Planned procedure below the ankle after the diagnostic angiography
Women who can have children, unless they have a negative pregnancy test or use contraception
Taking part in another trial that has not yet reached its main end point

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 120 years old?

Where in United States

Atlantic Medical ImagingVineland, United StatesContact: Laurie FrancoeurNo longer taking part
Endovascular ConsultantsWilmington, United StatesContact: Laurie FrancoeurNo longer taking part

About the trial

What the trial wants to find out

Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry")

Read full original descriptionShow less

A non-randomized clinical registry

This study is designed to obtain preliminary data on clinically relevant procedural variables during percutaneous below-knee artery revascularization procedures among consecutive patients treated with either the Finesse BTK Multicath® ("Finesse") or the standard of care using conventional angioplasty balloon catheters.

This registry will enroll participants with a history of chronic limb threatening ischemia and below-knee arterial insufficiency who will be assigned to revascularization with or without use of the Finesse BTK Multicath. The registry is an acute study examining procedural data only. The primary endpoints of interest are the volume of contrast used for the intervention, overall procedure time, radiation dose, number of catheter exchanges during revascularization, and medical device supply costs. For the first phase 12 consecutive patients will be treated with the standard of care. For the second phase 12 consecutive patients will be treated with Finesse.

24 participants total

Up to 5 study sites in the United States

Initial anticipated enrollment: Q4 2024 Last anticipated enrollment: Q2 2025

Patients >=18 years old with documented history of unilateral chronic limb threatening ischemia due to below-knee arterial insufficiency with angiographic runoff in the foot and limited arterial insufficiency above the knee

1. Contrast volume administered during the revascularization portion of a procedure. 2. Number of catheter exchanges during revascularization 3. Fluoroscopy time 4. Radiation dose during revascularization 5. Procedure time post-enrollment 6. Equipment costs 7. Reduced use of supplies 8. Technical success 9. Safety/Major Adverse Peripheral Events

On-treatment sample Intention-to-treat

The 2 groups in the trial

Standard of careExisting treatment, for comparison
Use of conventional single function crossing catheters, diagnostic catheters, angioplasty balloon catheters
Treatment: Standard of Care (SOC)
Finesse BTK MulticathTreatment being tested
Use of a multifunctional revascularization catheter
Treatment: Multicath