Deep Vein ThrombosisNCT06468150
Mechanical Thrombectomy and Catheter Directed Thrombolysis Utilization in Patients With Deep Vein Thrombosis
An observational study of Deep Vein Thrombosis, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
The goal of this observational study is to assess the utilization of mechanical thrombectomy and catheter-directed thrombolysis in patients with deep vein thrombosis in tertiary care. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- How many people
- 2,427 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2022to 1 Jun 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
- Adult, Older adult
Study population: Patients with deep vein thrombosis referred to the hospital from January 2022 to December 2023.
Who may be able to join
- lower limb, pelvic, or inferior vena cava deep vein thrombosis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Russia1 site
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Moscow, 117997
About this study
The goal of this observational study is to assess the utilization of mechanical thrombectomy and catheter-directed thrombolysis in patients with deep vein thrombosis in tertiary care. The main questions it aims to answer are:
- How many patients with deep vein thrombosis are potentially eligible for mechanical thrombectomy and catheter-directed thrombolysis in a tertiary hospital?
- What is the actual number of patients undergoing endovascular interventions for deep vein thrombosis?
Participants received endovascular treatment according to the clinical protocol of the treatment.
Read the detailed description
Tertiary hospital database was analyzed. All the records of patients referred for deep vein thrombosis were extracted. The collected data included general patient information, medical history, results of physical examination, duplex ultrasound, laboratory analysis, etc. Indications and contraindications for mechanical thrombectomy and catheter-directed thrombolysis were assessed, considering possible benefits and risks. Patients who could be eligible for this technique were identified
- Conditions
- Deep Vein Thrombosis
- Keywords
- Mechanical thrombectomy, catheter directed thrombolysis, iliofemoral deep vein thrombosis
- Medical subject headings
- Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with deep vein thrombosis who could be eligible for mechanical thrombectomy and catheter-directed thrombolysis
The number of participants with deep vein thrombosis who would fit the eligibility criteria for performing the intervention
Measured: from date of admission until the date of discharge, up to 1-2 weeks
Secondary outcomes (1)
The number of patients with deep vein thrombosis who underwent mechanical thrombectomy and catheter-directed thrombolysis
The number of participants with deep vein thrombosis who fitted the eligibility criteria and underwent the intervention.
Measured: from date of admission until the date of discharge, up to 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies 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
- Retrospective
- Enrolment
- 2,427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Zolotukhin, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468150
- Sponsor's protocol ID
- 224/22
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 21 Jun 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Thrombectomy and Catheter Directed Thrombolysis Utilization in Patients With Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT06468150
- Acronym / sponsor ID
- 224/22
- Conditions
- Deep Vein Thrombosis
- Keywords
- Mechanical thrombectomy, catheter directed thrombolysis, iliofemoral deep vein thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,427 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 Jun 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.
The goal of this observational study is to assess the utilization of mechanical thrombectomy and catheter-directed thrombolysis in patients with deep vein thrombosis in tertiary care. The main questions it aims to answer are:
- How many patients with deep vein thrombosis are potentially eligible for mechanical thrombectomy and catheter-directed thrombolysis in a tertiary hospital?
- What is the actual number of patients undergoing endovascular interventions for deep vein thrombosis?
Participants received endovascular treatment according to the clinical protocol of the treatment.
Detailed description
Tertiary hospital database was analyzed. All the records of patients referred for deep vein thrombosis were extracted. The collected data included general patient information, medical history, results of physical examination, duplex ultrasound, laboratory analysis, etc. Indications and contraindications for mechanical thrombectomy and catheter-directed thrombolysis were assessed, considering possible benefits and risks. Patients who could be eligible for this technique were identified
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with deep vein thrombosis referred to the hospital from January 2022 to December 2023.
Key inclusion criteria (1 listed)
- lower limb, pelvic, or inferior vena cava deep vein thrombosis
Key exclusion criteria (1 listed)
- -
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
Number of patients with deep vein thrombosis who could be eligible for mechanical thrombectomy and catheter-directed thrombolysis
Time frame: from date of admission until the date of discharge, up to 1-2 weeks
The number of participants with deep vein thrombosis who would fit the eligibility criteria for performing the intervention
1 secondary outcome
The number of patients with deep vein thrombosis who underwent mechanical thrombectomy and catheter-directed thrombolysis
Time frame: from date of admission until the date of discharge, up to 1-2 weeks
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 21 Jun 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 Deep Vein Thrombosis, 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 21 Jun 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?
Number of patients with deep vein thrombosis who could be eligible for mechanical thrombectomy and catheter-directed thrombolysis (time frame: from date of admission until the date of discharge, up to 1-2 weeks). 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 21 Jun 2024.