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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Operations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily). |
|
| Group 2 | Active Comparator | Standard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aorta-femoral bypass | Procedure | 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". |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Successful implantation of all devices without the need for conversion and with residual stenosis less than 30% | 1 day |
| 30-day complication rate | 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 days |
| 30-day primary patency rates | during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment. | 30 days |
| 30-day secondary patency rates | 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 | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular event (MACE) | composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death | 36 months |
| Limb salvage | preservation of a functional foot, eliminating the necessity for major amputation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrey Karpenko, MD, PhD | Novosibirsk Research Institute of Circulation Pathology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41776867 | Derived | Oganisyan SA, Saaya SB, Fattuloeva SS, Gostev AA, Cheban AV, Rabtsun AA, Bugurov SV, Osipova OS, Ignatenko PV, Starodubtsev VB, Mitrofanov VO, Karpenko AA. [Short- and medium-term results of open and endovascular treatment of steno-occlusive lesions of the iliac segment (TASC II C, D) in a randomized clinical trial]. Angiol Sosud Khir. 2023 Mar 30;29(1):79-88. doi: 10.33029/1027-6661-2023-29-1-79-88. Russian. |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| Recanalization and stenting of aorta-iliac segment | Procedure | 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). |
|
| Therapy: aspirin and clopidogrel | Drug | prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily). |
|
| 36 months |
| Amputation-free survival | freedom from major limb amputation or death by any cause | 36 months |
| Primary patency rates | no occlusion or significant flow-limiting stenosis in the treated segment | 36 months |
| Secondary patency rates | no occlusion or flow-limiting stenosis following at least one re-intervention aimed at restoring patency, in addition to all instances of primary patency | 36 months |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |