NCT02580084.
| Trial name or title | Prospective randomized clinical study of the aorta‐femoral bypass and hybrid intervention and the iliac arteries with stenting and plasty of the common femoral artery effectiveness in patients with the iliac segment and femoral artery occlusive disease (TASC C, D) |
| Methods | Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: single group assignment Masking: single blind (subject) Primary purpose: treatment |
| Participants | Individuals with chronic lower limb ischaemia (Rutherford classification 4‐6) |
| Interventions | Aorto‐femoral bypass Hybrid intervention (common femoral endarterectomy and iliac balloon angioplasty or stenting) |
| Outcomes | Primary outcome measures: 30‐day mortality Secondary outcome measures: primary patency, secondary patency, preservation of the operated limb, lymphorrhoea in the area of intervention, infection/septic complications, haematoma, myocardial infarction |
| Starting date | August 2015 |
| Contact information | Vyacheslav Mitrofanov, v_mitrofanov@meshalkin.ru |
| Notes |
NCT02580084 Sponsors and Collaborators: Meshalkin Research Institute of Pathology of Circulation |