Clinical trial NCT02580084: 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)
Official title: Prospective Randomized 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis of the Peripheral Arteries
Keywords: atherosclerosis of the peripheral arteries
Aorta-femoral Bypass
Hybrid Intervention
Iliac Arteries With Stenting and Plasty of the Common Femoral Artery
plastic arteries with lesions of the common femoral artery and deep femoral artery
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-10-20
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

According to different studies, 76% occlusive aorta-iliac article course patients indicate femoral-popliteal segment lesions. Due to the lack of inflow and outflow ways of correction needed for adequate limb revascularization surgery treatment of multistorey atherosclerotic lesions patients is still one of the most complex problems of vascular surgery. Perioperational mortality of critical limb ischemia patients reaches 5-10% in retrograde aorta-iliac segment reconstruction.

Due to its high efficiency hybrid operative invasion is one of the most perspective directions in reconstructive vascular surgery development (92-98% of the cases with the small number of post-operative complications).

Furthermore, hybrid surgery is possible with the critical iliac segment and femoral artery lesions, since stenting in the field of physiological bends (femoral artery) may lead to its breaking and artery thrombosis. Arterial segments blood flow reconstruction is possible with hybrid innervations meaning iliac segment stenting and common femoral artery patch.

All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. 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, together with hybrid technics implementation in this category of patients.

Eligibility criteria: Inclusion Criteria:

* Patients with occlusive lesions of C and D type iliac segment and steno-occlusive lesions of the common femoral artery, and with chronic lower limb ischemia (II-IV degree by Fontaine, 2-5 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 classification.
* Patients who have suffered a stroke or myocardial infarction less than 3 months
* Significant Steno-occlusive lesion of the contralateral side
* Decompensated chronic "pulmonary" heart
* Aortoarteritis
* 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
* Expressed aortic calcification tolerant to angioplasty
* Patient refusal to participate or continue to participate in the study

Primary outcomes:
measure: Safety assessment in the 30-day period: clinically significant bleeding, hematoma, infection of the prosthesis, infection of the postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment
timeFrame: 30 days
measure: Evaluation of efficiency: primary patency, secondary patency success of procedures, length of hospital stay
timeFrame: 30 days
measure: Evaluation of efficiency: success of procedures
timeFrame: 30 days
Secondary outcomes:
measure: mortality
timeFrame: during the whole period of observation. Observation is 36 month after surgery
measure: stroke
timeFrame: during the whole period of observation. Observation is 36 month after surgery
measure: myocardial infarction
timeFrame: during the whole period of observation. Observation is 36 month after surgery
measure: limb salvage
timeFrame: in the early postoperative period. Surveillance is 36 month after surgery
measure: infection of the prosthesis
timeFrame: during the whole period of observation. Observation is 36 month after surgery
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: NRICP
Study officials:
References:
citation: Starodubtsev V, Mitrofanov V, Ignatenko P, Gostev A, Preece R, Rabtsun A, Saaya S, Popova I, Karpenko A. Editor's Choice - Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial. Eur J Vasc Endovasc Surg. 2022 Apr;63(4):557-565. doi: 10.1016/j.ejvs.2022.02.002. Epub 2022 Feb 9.