Clinical trial NCT02948166: Remote Endarterectomy and Endovascular Treatments in Patients With the Femoral Artery Occlusive Disease
Official title: Prospective Randomized Clinical Trial of the Remote Endarterectomy and the Femoral Arteries Endovascular Treatments in Patients With the Femoral Artery Occlusive Disease (TASC C, D)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Steno-occlusive Desease of Femoro-popliteal Arterial Segment
Keywords: remote endarterectomy
Angioplasty with stenting of the superficial femoral artery
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-10-28
Enrollment: 174
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of two methods for revascularization of the superficial femoral artery: remote endarterectomy vs. stenting of the superficial femoral artery cin patients with steno-occlusive lesion of the femoro-popliteal segment of TASC C, D

Detailed description: Reported local percutaneous angioplasty and stenosis of femoral popliteal arteries indicate that the primary technical and clinical success above 95%. The technical success of recanalization of long occlusions femoral arteries less than 80%. Improvement of endovascular equipment designed for the treatment of total occlusions, increases the technical success of recanalization. The materials of the TASC II summarizes the results of several large studies that presented data on the operated segment artery patency at 56-73,7% within 2 years of observation. An alternative method of revascularization own femoral artery is remote endarterectomy. The two-year primary patency at remote endarterectomy is 86% (Moll F.L., Iio G.H. Closed superficial femoral artery endarterectomy: a 2-year follow up. Cardiovasc Surg. 1997; 5: 398-400). Primary assisted patency for 33 months 88% (Rosenthal D, Martin JD, Schubart PJ, Wellons ED. Remote. superﬁcial femoral artery endarterectomy. J Cardiovasc Surg. (Torino) 2004; 45: 185-192). The length of the occlusion is not a limitation to the use of remote endarterectomy. Primary patency at 31 months was 60%.

Eligibility criteria: Inclusion Criteria:

* Patients with occlusive lesions of C and D type femoral artery and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford)
* Patients who consented to participate in this study.

Exclusion Criteria:

* Chronic heart failure of III-IV functional class by 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
* Patients with significant common femoral artery lesion
* Patient refusal to participate or continue to participate in the study

Primary outcomes:
measure: the change of lumen in target vessel
timeFrame: Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years
Secondary outcomes:
measure: Number of participants with a successful procedure of revascularization.
timeFrame: During the operation.
measure: Number of participants with complications during the operation.
timeFrame: During the operation.
measure: Number of participants with limb salvage
timeFrame: Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Study officials:
affiliation: cientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
name: Andrey Karpenko
role: STUDY_DIRECTOR
References: