Clinical trial NCT03315884: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis of the Peripheral Arteries
Keywords: TASC C, D
CFA
Supera
iliac arteries
common femoral artery
plasty of the common femoral artery
stenting Supera
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Abbott
First posted: 2017-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 47
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary patency of the operated segment
timeFrame: during the whole period of observation. Observation is 24 month after surgery
Secondary outcomes:
measure: Secondary patency of the operated artery restenosis
timeFrame: during the whole period of observation. Observation is 24 month after surgery
measure: reocclusion
timeFrame: during the whole period of observation. Observation is 24 month after surgery
measure: postoperative bleeding
timeFrame: in the early postoperative period. Surveillance is 30 days after surgery
measure: hematoma
timeFrame: in the early postoperative period. Surveillance is 30 days after surgery
measure: myocardial infarction
timeFrame: during the whole period of observation. Observation is 24 month after surgery
measure: mortality
timeFrame: during the whole period of observation. Observation is 24 month after surgery
measure: limb amputation
timeFrame: during the whole period of observation. Observation is 24 month after surgery
measure: infection
timeFrame: during the whole period of observation. Observation is 24 month after surgery
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: NRICP
Study officials:
References: