Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04391374
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2020-05-13
Brief Title:
Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease
Sponsor:
Ryazan State Medical University
Organization:
Ryazan State Medical University
Study Overview
Official Title:
The Role of Hemostatic Markers of Endothelial Dysfunction in the Development of Disease Progression Thrombotic Complications and Restenosis in Patients With Atherosclerotic Peripheral Artery Disease
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 patients preferences
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 patients preferences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None