Drug Coated Balloon Clinical Trial
— DCBOfficial title:
Outcomes of Drug Coated Balloon Angioplasty for Femoropopliteal Lesions in Patients With Critical Limb Ischemia
Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | March 2023 |
Est. primary completion date | March 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from device- and procedure-related mortality | mortality related to procedure | 30 days | |
Primary | 30 days clinically driven target vessel revascularization | patency rate | 30 days | |
Secondary | Major adverse events | major adverse events as amputation | 12 months | |
Secondary | 1 year clinically driven target vessel revascularization | patency rate | 12 months |