Status:
UNKNOWN
Drug Coated Ballon in Critical Limb Ischemia
Lead Sponsor:
Assiut University
Conditions:
Drug Coated Balloon
Eligibility:
All Genders
20-90 years
Phase:
NA
Brief Summary
Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)
Detailed Description
Critical limb ischemia (CLI) is the most advanced stage of peripheral artery disease (PAD); which is estimated to affect more than 200 million people worldwide.(1) CLI classified as Rutherford categor...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adults at least 18 years of age with critical lower limb ischemia (Rutherford category 4, 5), stenotic (≥70% by visual angiographic assessment) or occlusive lesions in the native SFA or PPA, and vessel diameter ≥4 and ≤6 mm were eligible.
- Total lesion length ≤190 mm (visual angiographic assessment).
- DE novo angioplasty
- Recurrent or recoil lesion
- Exclusion criteria:
- pregnancy
- breast feeding
- iliac lesions
- Malignancy
- Patients with raised renal chemistry.
- Patients with contraindication to antiplatelet therapy.
Exclusion
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04737291
Start Date
March 15 2021
End Date
March 1 2023
Last Update
February 3 2021
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