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

NCT06906055 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-04-02

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DEVICE

Multicath

Use of a multifunctional catheter for revascularization of blocked arteries below the knee

DEVICE

Standard of Care (SOC)

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

Sponsors & Collaborators

  • Summa Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2025-12-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06906055 on ClinicalTrials.gov