Clinical trial NCT06906055: Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Official title: Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease Below the Knee
Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
Keywords: angioplasty
limb threatening ischemia
amputation
diabetes
chronic kidney disease
ischemic ulcer
rest pain
gangrene
atherosclerosis
Lead sponsor: Summa Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Contrast volume
timeFrame: during the intervention/procedure/surgery
Secondary outcomes:
Other outcomes:
measure: Procedure duration
timeFrame: during the intervention
measure: Radiation dose
timeFrame: during the intervention
measure: Fluoroscopy time
timeFrame: during the intervention
measure: Number of catheter exchanges
timeFrame: during the intervention
measure: Equipment costs
timeFrame: during the intervention
measure: Rate of use of microcatheters or diagnostic catheters
timeFrame: during the intervention/procedure/surgery
measure: Rate of technically successful revascularization of a continuous artery in the calf
timeFrame: during the intervention/procedure/surgery
measure: Adverse events
timeFrame: during the intervention
Locations:
city: Wilmington
country: United States
facility: Endovascular Consultants
state: Delaware
city: Vineland
country: United States
facility: Atlantic Medical Imaging
state: New Jersey
Study officials:
References: