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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)

NCT02580084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2021-10-11

No results posted yet for this study

Summary

Currently, according to the TASC II consensus document (2007) and the Russian guidelines for limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is suggested.

Conditions

  • Atherosclerosis of the Peripheral Arteries

Interventions

PROCEDURE

Hybrid Intervention

The puncture of the femoral artery general is executed and the introducer 7Fr is set. Further, the hydrophilic conductor executes a recanalization of the Vasa of iliac artery occlusion. if you cannot pass the occlusion retrograde is additional access to antegrade recanalization. Then using hydrophilic conductors, an iliac artery antegrade or retrograde recanalization of the Vasa is made. Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Balloon angioplasty and stenting, iliac artery is done, the controlling angiography Closing maims.

PROCEDURE

Aorta femoral Bypass

It is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed.

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-08-31
Completion
2021-03-31

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 NCT02580084 on ClinicalTrials.gov