Status:
NOT_YET_RECRUITING
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Lead Sponsor:
Summa Therapeutics, LLC
Conditions:
Peripheral Arterial Disease Below the Knee
Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
Eligibility:
All Genders
18-120 years
Phase:
NA
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06906055
Start Date
April 3 2025
End Date
June 30 2026
Last Update
April 2 2025
Active Locations (2)
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1
Endovascular Consultants
Wilmington, Delaware, United States, 19805
2
Atlantic Medical Imaging
Vineland, New Jersey, United States, 08360