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

Summa Therapeutics, LLC

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease Below the Knee; Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization

Treatments: Device: Standard of Care (SOC); Device: Multicath

Study type: Interventional

Funder types: Industry

Identifiers

NCT06906055

CT-0119-01

Details and patient eligibility

About

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

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Use of conventional single function crossing catheters, diagnostic catheters, angioplasty balloon catheters

Treatment:

Device: Standard of Care (SOC)

Finesse BTK Multicath

Experimental group

Description:

Use of a multifunctional revascularization catheter

Treatment:

Device: Multicath