Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
Conditions
Keywords
angioplasty, limb threatening ischemia, amputation, diabetes, chronic kidney disease, ischemic ulcer, rest pain, gangrene, atherosclerosis
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
Interventions
DEVICEMulticath
Use of a multifunctional catheter for revascularization of blocked arteries below the knee
DEVICEStandard of Care (SOC)
Use of single function crossing catheters, diagnostic catheters, angioplasty balloon catheters
Sponsors
Summa Therapeutics, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contrast volume | during the intervention/procedure/surgery |
Other
| Measure | Time frame |
|---|---|
| Radiation dose | during the intervention |
| Fluoroscopy time | during the intervention |
| Number of catheter exchanges | during the intervention |
| Procedure duration | during the intervention |
| Rate of use of microcatheters or diagnostic catheters | during the intervention/procedure/surgery |
| Rate of technically successful revascularization of a continuous artery in the calf | during the intervention/procedure/surgery |
| Adverse events | during the intervention |
| Equipment costs | during the intervention |
Countries
United States
Contacts
Primary ContactTimothy Murphy, M.D.
Outcome results
None listed