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

Not Applicable

• Conditions: Atherosclerosis of the Peripheral Arteries
• Interventions: Procedure: Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA); Procedure: Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch

• Registration Number: NCT03315884
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Study Start: 2017-12-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary patency of the operated segment	during the whole period of observation. Observation is 24 month after surgery	during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities

Secondary Outcome Measures

Name	Time	Method
reocclusion	during the whole period of observation. Observation is 24 month after surgery	during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
mortality	during the whole period of observation. Observation is 24 month after surgery
Secondary patency of the operated artery restenosis	during the whole period of observation. Observation is 24 month after surgery	during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
postoperative bleeding	in the early postoperative period. Surveillance is 30 days after surgery	assessment of bleeding within 30 days after surgery. The identification of bleeding with physical examination and ultrasound.Considered bleeding requiring surgical intervention
hematoma	in the early postoperative period. Surveillance is 30 days after surgery
limb amputation	during the whole period of observation. Observation is 24 month after surgery
infection	during the whole period of observation. Observation is 24 month after surgery
myocardial infarction	during the whole period of observation. Observation is 24 month after surgery

Trial Locations

Locations (1)

NRICP; 🇷🇺 Novosibirsk, Russian Federation