Peripheral Artery DiseaseNCT04391374
Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease
An observational study of Peripheral Artery Disease and Restenosis of Peripheral Vascular Stent, run by Ryazan State Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Restenosis of Peripheral Vascular Stent, Restenosis, Vascular Graft
- What is being tested?
- an arterial reconstructive procedure
- Type of treatment
- Surgery or procedure
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 23 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Males or females older than 40 years of age;
- Presence of peripheral arterial disease of atherosclerotic origin.
Who cannot join
- Males or females younger than 40 years of age;
- Chronic lower limb ischemia of other ethiology (Buerger's disease, aortoarteritis etc.);
- Active cancer or remission period less than 5 years;
- Decompensated diabetes mellitus;
- Pregnancy or breast-feeding for females.
About this study
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
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.
Read the 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 patient's preferences.
- Conditions
- Peripheral Artery Disease, Restenosis of Peripheral Vascular Stent, Restenosis, Vascular Graft, Endothelial Dysfunction
- Being tested
- an arterial reconstructive procedure
- Keywords
- hemostasis, endothelial dysfunction, restenosis, thrombosis
- Medical subject headings
- Peripheral Arterial Disease, Graft Occlusion, Vascular, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an arterial reconstructive procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: an arterial reconstructive procedure | |
| 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 Receives: Procedure: an arterial reconstructive procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombosis
incidence of thrombotic complications in the target arterial segment
Measured: 1 year
restenosis
incidence of restenosis in the target arterial segment
Measured: 1 year
progression of atherosclerosis
detection of newly formed or progressing peripheral atherosclerotic lesions
Measured: 1 year
Secondary outcomes (3)
limb salvage rate
limb salvage rate in the target extremity
Measured: 1 year
acute myocardial infarction
incidence of acute myocardial infarction
Measured: 1 year
mortality rate
overall mortality rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study startJan 2017
- Primary completion23 Feb 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Mzhavanadze, MD, PhD, Principal investigator, RyazSMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391374
- Sponsor's protocol ID
- 05/18
- Status last verified
- May 2023
- First submitted
- 13 May 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
Publications
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.
PubMed 34349046Kalinin 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.
PubMed 30113592
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04391374
- Acronym / sponsor ID
- 05/18
- Conditions
- Peripheral Artery Disease, Restenosis of Peripheral Vascular Stent, Restenosis, Vascular Graft, Endothelial Dysfunction
- Keywords
- hemostasis, endothelial dysfunction, restenosis, thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's preferences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: an arterial reconstructive procedureSubjects 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 | – | Procedure: an arterial reconstructive procedureSubjects with atherosclerotic peripheral artery disease who undergo endovascular balloon angioplasty and stenting with bare-metal stents in aorto-iliac or femoro-popliteal position |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Males or females older than 40 years of age;
- Presence of peripheral arterial disease of atherosclerotic origin.
Key exclusion criteria (5 listed)
- Males or females younger than 40 years of age;
- Chronic lower limb ischemia of other ethiology (Buerger's disease, aortoarteritis etc.);
- Active cancer or remission period less than 5 years;
- Decompensated diabetes mellitus;
- Pregnancy or breast-feeding for females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| an arterial reconstructive procedure | Procedure or surgery | Peripheral artery balloon angioplasty and stenting, Peripheral artery bypass grafting |
Primary outcome
thrombosis
Time frame: 1 year
incidence of thrombotic complications in the target arterial segment
restenosis
Time frame: 1 year
incidence of restenosis in the target arterial segment
progression of atherosclerosis
Time frame: 1 year
detection of newly formed or progressing peripheral atherosclerotic lesions
3 secondary outcomes
limb salvage rate
Time frame: 1 year
acute myocardial infarction
Time frame: 1 year
mortality rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Results publication: PubMed 34349046Kalinin 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.
- Results publication: PubMed 30113592Kalinin 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.
- Individual participant dataSharing planned: Undecided. Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
Related trials for Peripheral Artery Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Mzhavanadze, MD, PhD principal investigator
RyazSMU
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Restenosis of Peripheral Vascular Stent, run by Ryazan State Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thrombosis (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391374, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.