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Study of the AFB and Stenting of the Iliac Arteries

NCT02209350 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2025-01-15

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Principal Investigators

  • Andrey Karpenko, MD, PhD · Novosibirsk Research Institute of Circulation Pathology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-02
Primary Completion
2020-11-01
Completion
2020-11-02

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02209350 on ClinicalTrials.gov