Study of the AFB and Stenting of the Iliac Arteries

PHASE1CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

August 2, 2015

Primary Completion Date

November 1, 2020

Study Completion Date

November 2, 2020

Conditions
Aorta-iliac Segment Lesion (C,D Type by TASC II)
Interventions
PROCEDURE

Aorta-femoral bypass

"Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta.~Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of end-to-side in the reconstruction by shunting.~After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of end-to-side. If antegrade flow is absent, anastomosis is formed in the sort of end to end."

PROCEDURE

Recanalization and stenting of aorta-iliac segment

"Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized.~Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often mixed) artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter)."

DRUG

Therapy: aspirin and clopidogrel

prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Trial Locations (1)

630055

Novosibirsk Research Institute of Circulation Pathology, Novosibirsk

All Listed Sponsors
lead

Meshalkin Research Institute of Pathology of Circulation

NETWORK

NCT02209350 - Study of the AFB and Stenting of the Iliac Arteries | Biotech Hunter | Biotech Hunter