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The study is aimed at evaluating the role of the activity of the key hemostatic parameters of endothelial dysfunction (nitric oxide II (NO) metabolites, plasmin activator inhibitor-1 (PAI-1), von Willebrand factor (vWF), coagulation factor VIII (FVIII), soluble endothelial protein C receptors (sEPCR)) in the development of disease progression, thrombotic complications and restenosis in subjects with atherosclerotic peripheral artery disease.
The study will involve patients with atherosclerotic peripheral artery disease (Rutherford category 3-5). The subjects are to be divided into three groups:
Group A: patients who undergo bypass surgery with a synthetic graft on aorto-iliac or femoro-popliteal segment; Group B: patients who undergo endovascular balloon angioplasty and stenting on aorto-iliac or femoro-popliteal segment; Group C: patients who undergo standard of care conservative treatment.
Decisions on revascularization or conservative treatment alone is to be made by a team of vascular specialists in accordance with the severity of the disease, previous treatment, anatomy, possible need for repeat procedures in the future, and patient's preferences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative treatment | Subjects with atherosclerotic peripheral artery disease (PAD) who undergo standard of care conservative treatment according to the current PAD guidelines. | ||
| Peripheral artery bypass grafting | Subjects with atherosclerotic peripheral artery disease who undergo an open bypass grafting with synthetic prosthesis in aorto-iliac or femoro-popliteal position |
| |
| Peripheral artery balloon angioplasty and stenting | Subjects with atherosclerotic peripheral artery disease who undergo endovascular balloon angioplasty and stenting with bare-metal stents in aorto-iliac or femoro-popliteal position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| an arterial reconstructive procedure | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| thrombosis | incidence of thrombotic complications in the target arterial segment | 1 year |
| restenosis | incidence of restenosis in the target arterial segment | 1 year |
| progression of atherosclerosis | detection of newly formed or progressing peripheral atherosclerotic lesions | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| limb salvage rate | limb salvage rate in the target extremity | 1 year |
| acute myocardial infarction | incidence of acute myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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A prospective study is aimed at enrolling 200 patients with atherosclerotic peripheral arterial disease, Rutherford category 3-5. The patients with PAD are scheduled to undergo either open or endovascular reconstructive procedures on aorto-iliac and femoro-popliteal segment or conservative treatment alone. The subjects of similar age, sex, and ethnicity are to be divided into three groups, respectively.
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| Name | Affiliation | Role |
|---|---|---|
| Nina Mzhavanadze, MD, PhD | RyazSMU | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34349046 | Result | Kalinin RE, Suchkov IA, Mzhavanadze ND, Zhurina ON, Klimentova EA, Povarov VO. Coagulation Factor Activity and Hemostatic Markers of Endothelial Dysfunction in Patients with Peripheral Arterial Disease. Vasc Specialist Int. 2021 Aug 5;37:26. doi: 10.5758/vsi.210010. | |
| 30113592 | Result | Kalinin RE, Suchkov IA, Mzhavanadze ND, Demikhov VG, Zhurina ON, Klimentova EA. [Hemostatic changes in patients with peripheral artery disease before and after bypass surgery]. Khirurgiia (Mosk). 2018;(8):46-49. doi: 10.17116/hirurgia2018846. Russian. |
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Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D006083 | Graft Occlusion, Vascular |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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peripheral blood samples for the assessment of the concentration of NO metabolites, PAI-1, sEPCR, and activity of vWF, FVIII.
| 1 year |
| mortality rate | overall mortality rate | 1 year |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |