NCT02209350

Study of the AFB and Stenting of the Iliac Arteries

Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).

Conditions

• Aorta-iliac Segment Lesion (C,D Type by TASC II)

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-08-02
• Primary completion: 2020-11-01
• Completion: 2020-11-02
• First posted: 2014-08-05
• Last updated: 2025-01-15

Locations

1 site across 1 country: Russia