Deep Venous ThrombosisVETTORNCT02113475
Venous Thrombectomy/Thrombolysis Outcome Registry
An observational study of Deep Venous Thrombosis and Post Thrombotic Syndrome, run by Heart and Vascular Outcomes Research Institute at 1 site in United States.
Trial summary
Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The Registry will track patient outcome and quality of life over 60 months for treatment with anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in accordance with current treatment guidelines . Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Deep Venous Thrombosis, Post Thrombotic Syndrome
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2021
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participating study centers will enroll patients and enter data in the web-based registry that include demographics, clinical features,
Who may be able to join
- •Data obtained in line with good clinical practice, applicable laws and regulation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Heart & Vascular Outcomes Research Institute
Beverly, Massachusetts, 01915
About this study
Official title: A Patient Outcome Study After Pharmacomechanical Catheter-directed Thrombolysis and Standard Treatment for Venous Thrombosis
Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The Registry will track patient outcome and quality of life over 60 months for treatment with anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in accordance with current treatment guidelines .
- Conditions
- Deep Venous Thrombosis, Post Thrombotic Syndrome
- Keywords
- CDT, PCDT, DVT, PTS, Quality of Life
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life,
Measured: 60 months
Secondary outcomes (1)
Rate of Post-Thrombotic Syndrome
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous 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
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Vascular Outcomes Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uchenna N Onyeachom, Study director, Heart and Vascular Outcomes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113475
- Sponsor's protocol ID
- PC14-1213-001
- Acronym
- VETTOR
- Status last verified
- Mar 2015
- First submitted
- 9 Apr 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Outcome Study After Pharmacomechanical Catheter-directed Thrombolysis and Standard Treatment for Venous Thrombosis
- ClinicalTrials.gov ID
- NCT02113475
- Acronym / sponsor ID
- VETTOR / PC14-1213-001
- Conditions
- Deep Venous Thrombosis, Post Thrombotic Syndrome
- Keywords
- CDT, PCDT, DVT, PTS, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Heart and Vascular Outcomes Research InstituteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 14 Apr 2014 (estimated)
- 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.
Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The Registry will track patient outcome and quality of life over 60 months for treatment with anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in accordance with current treatment guidelines .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participating study centers will enroll patients and enter data in the web-based registry that include demographics, clinical features,
Key inclusion criteria (1 listed)
- •Data obtained in line with good clinical practice, applicable laws and regulation
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
Quality of Life,
Time frame: 60 months
1 secondary outcome
Rate of Post-Thrombotic Syndrome
Time frame: 60 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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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.
Uchenna N Onyeachom study director
Heart and Vascular Outcomes Research Institute
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 Venous Thrombosis and Post Thrombotic Syndrome, run by Heart and Vascular Outcomes Research Institute at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 19 Mar 2015. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uchenna N Onyeachom (978-927-7800, uonyeachom@hvori.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life, (time frame: 60 months). 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 19 Mar 2015.