Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Not yet recruitingNot applicableNCT06906055
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- 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
- Interventions
- Device: Multicath
- Device: Standard of Care (SOC)
- Sponsor
- Summa Therapeutics, LLC
- Start date
- 2025-04-03
- Primary completion
- 2025-12-31
- Sex
- All
- Age range
- from 18 Years to 120 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06906055