Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery (TASC CD)

Meshalkin Research Institute of Pathology of Circulation

Status: Unknown

Conditions: Atherosclerosis of the Peripheral Arteries

Treatments: Procedure: Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch; Procedure: Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT03315884

NRICP112

Details and patient eligibility

About

According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions.

Full description

According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions. Patients with type C lesions can be managed by either stenting or bypass surgery. Despite the fact that aorta-femoral reconstructions long-term results are better than the diffuse aorta-iliac lesions endovascular treatment results, the surgery risk is significantly higher than the endovascular surgery risk regarding criteria of mortality, complications, and return to normal activity.

All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. The figure reaches 100% in the case of local lesions. The technical success of iliac arteries long occlusions recanalization reaches 80-85%. Improvement of endovascular equipment designed for the total occlusions treatment increases technical success of recanalization. The TASC II materials summarize the several large studies results which present the data on the operated segment artery patency at the level of 70-81% within 5-8 years of follow up. A large number of authors note the actuality of aortic-iliac type C and D segment lesions endovascular treatment recommendations revision according to the TASC II.

Enrollment: 60 estimated patients

Sex: All

Ages: 47 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with occlusive lesions of C and D type iliac segment and CFA lesion, and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford), age: 47-75 years old.
• Patients who consented to participate in this study.

Exclusion criteria

• Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
• Decompensated chronic "pulmonary" heart
• Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
• Polyvalent drug allergy
• Cancer in the terminal stage with a life expectancy less than 6 months;
• Acute ischemic
• Expressed aortic calcification tolerant to angioplasty
• Patient refusal to participate or continue to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Iliac segment recanalization and stenting Iliac segment CFA

Experimental group

Description:

Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)

Treatment:

Procedure: Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch

Iliac segment recanalization, stenting and plastic CFA patch

Active Comparator group

Description:

Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch

Treatment:

Procedure: Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)