Varicose VeinsNCT06332833
Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery
An observational study of Varicose Veins and Peripheral Arterial Disease, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Peripheral Arterial Disease
- How many people
- 285 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2023to 31 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PAD having superficial femoral artery (SFA) occlusion.
Who may be able to join
- Older than 18 Years
Who cannot join
- Those unwilling to sign an informed consent were also included.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Veronika Golovina
Moscow, Pirogov Russian National Research Medical University, 109044
About this study
Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed.
Read the detailed description
Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. The investigators registered presence of varicose veins, type of previous invasive procedure and availability of saphenous trunks as possible grafts
- Conditions
- Varicose Veins, Peripheral Arterial Disease
- Keywords
- varicose veins, Peripheral Arterial Disease, phlebectomy
- Medical subject headings
- Varicose Veins, Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
availability of saphenous trunks as possible grafts
availability of saphenous trunks as possible grafts (Yes|No)
Measured: at the moment of inclusion
Secondary outcomes (2)
presence of varicose veins
presence of varicose veins (Yes|No)
Measured: at the moment of inclusion
type of previous invasive procedure
Phlebectomy\ radiofrequency ablation\ endovenous laser ablation (Yes|No)
Measured: at the moment of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Dec 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies 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
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332833
- Sponsor's protocol ID
- 235
- Status last verified
- Dec 2023
- First submitted
- 15 Mar 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery
- ClinicalTrials.gov ID
- NCT06332833
- Acronym / sponsor ID
- 235
- Conditions
- Varicose Veins, Peripheral Arterial Disease
- Keywords
- varicose veins, Peripheral Arterial Disease, phlebectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Mar 2024 (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.
Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed.
Detailed description
Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. The investigators registered presence of varicose veins, type of previous invasive procedure and availability of saphenous trunks as possible grafts
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PAD having superficial femoral artery (SFA) occlusion.
Key inclusion criteria (1 listed)
- Older than 18 Years
Key exclusion criteria (1 listed)
- Those unwilling to sign an informed consent were also included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
availability of saphenous trunks as possible grafts
Time frame: at the moment of inclusion
availability of saphenous trunks as possible grafts (Yes|No)
2 secondary outcomes
presence of varicose veins
Time frame: at the moment of inclusion
type of previous invasive procedure
Time frame: at the moment of inclusion
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 7 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Peripheral Arterial Disease, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 1 inclusion and 1 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
availability of saphenous trunks as possible grafts (time frame: at the moment of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024.