Aorta-iliac Segment Lesion (C,D Type by TASC II)
Conditions
Brief summary
The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).
Interventions
PROCEDUREAorta-femoral bypass
Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta. Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of end-to-side in the reconstruction by shunting. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of end-to-side. If antegrade flow is absent, anastomosis is formed in the sort of end to end.
PROCEDURERecanalization and stenting of aorta-iliac segment
Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized. Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often mixed) artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter).
DRUGTherapy: aspirin and clopidogrel
prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with unilateral steno-occlusive iliac lesions (TASC types C, D) and with chronic lower limb ischemia * Rutherford classification category 3-5 chronic limb ischemia, * age: 45-75 years old. * Patients who consented to participate in this study.
Exclusion criteria
* Aortic thrombosis, concomitant abdominal aortic or iliac aneurysms, acute limb ischemia or vasculitis; * Flush occlusion of the common iliac artery; * Ipsilateral common femoral arteries steno-occlusive disease (occlusion or stenosis \>50%); * Ipsilateral profunda femoris artery steno-occlusive disease (occlusion or stenosis \>50%); * Refusal to participate in the study; * Stroke or myocardial infarction within the past 3 months; * Ischemic heart disease with New York Heart Association functional class IV; * Malignant tumor with an estimated life span of under 6 months; * Previous ipsilateral or contralateral surgery (bypass, hybrid or stenting); * Hepatic or renal insufficiency (bilirubin\> 35 mmol/l, glomerular filtration rate \<60 ml/min/1.73 m2); * Severe calcification of the aorta and iliac arteries intolerant to balloon angioplasty (as determined by the Peripheral Arterial Calcification Scoring System on computed tomography angiography as interpreted by a vascular radiologist):12 * unilateral calcification ≥ 5cm (Grade 2), bilateral calcification ≥ 5cm (Grade 4) or circumferential calcification , defined as 270°-360° around the circumference of aorta and/or iliac arteries.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 1 day | Successful implantation of all devices without the need for conversion and with residual stenosis less than 30% |
| 30-day complication rate | 30 days | clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism |
| 30-day primary patency rates | 30 days | during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment. |
| 30-day secondary patency rates | 30-day | during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment after reintervention due to thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular event (MACE) | 36 months | composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death |
| Secondary patency rates | 36 months | no occlusion or flow-limiting stenosis following at least one re-intervention aimed at restoring patency, in addition to all instances of primary patency |
| Limb salvage | 36 months | preservation of a functional foot, eliminating the necessity for major amputation |
| Amputation-free survival | 36 months | freedom from major limb amputation or death by any cause |
| Primary patency rates | 36 months | no occlusion or significant flow-limiting stenosis in the treated segment |
Countries
Russia
Outcome results
None listed