Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting Supera and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac and CFA Segment Occlusive or Stenosis Disease (TASC C, D)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Primary patency of the operated segment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 47 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Iliac segment recanalization and stenting Iliac segment CFA
Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)
Intervention: Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch (Procedure)
Iliac segment recanalization, stenting and plastic CFA patch
Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
Intervention: Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA) (Procedure)
Outcomes
Primary Outcomes
Primary patency of the operated segment
Time Frame: 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 Outcomes
- reocclusion(during the whole period of observation. Observation is 24 month after surgery)
- 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)
- postoperative bleeding(in the early postoperative period. Surveillance is 30 days after surgery)
- 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)