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. 2017 Apr 3;2017(4):CD002000. doi: 10.1002/14651858.CD002000.pub3

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