NCT06906055Not yet recruiting
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 3 Apr 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Summa Therapeutics, LLC
- Diseases
- Chronic kidney disease
- NCT number
- NCT06906055
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 3 Apr 2025 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atlantic Medical Imaging Coordinator of this site? Confirm its status | Vineland | United States | Unknown status |
| Endovascular Consultants Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.