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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• Multicath — DEVICE
  Use of a multifunctional catheter for revascularization of blocked arteries below the knee
• Standard of Care (SOC) — DEVICE
  Use of single function crossing catheters, diagnostic catheters, angioplasty balloon catheters

Study Details

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

Key Dates

Start date

Apr 3, 2025

Status verified

Mar 2025

Primary completion

Dec 31, 2025

Completion

Jun 30, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard of care
  Use of conventional single function crossing catheters, diagnostic catheters, angioplasty balloon catheters
• Experimental: Finesse BTK Multicath
  Use of a multifunctional revascularization catheter

Primary Outcome Measure

Contrast volume [ Time Frame: during the intervention/procedure/surgery ]

Central Contacts

• Timothy Murphy, M.D.
  8772672685
  [email protected]

Locations (2)

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