Venous Thrombo-embolismNCT01367184
National Inferior Vena Cava (IVC) Filter Registry
An observational study of Venous Thrombo-embolism, run by American Venous Forum at 27 sites in United States.
Trial summary
Inferior vena cava (IVC) filter is an important therapeutic device used in the management of venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Thrombo-embolism
- How many people
- 20,000 participants
- Where
- 27 sitesUnited States
- Study dates
- May 2011to May 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: No specific criteria. Data from anyone who underwent IVC Filter Placement/Retrieval will be eligible
Who may be able to join
- Data obtained in line with good clinical practice,applicable laws and regulation
Who cannot join
None listed.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Northwest Texas Hospital
Amarillo, Texas, 79106
University Of Michigan Health System
Ann Arbor, Michigan, 48109-5867
St. Luke's Medical Center
Chesterfield, Missouri, 63017
University of Chicago Hospitals
Chicago, Illinois, 60637
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Palmetto Health and Providence Hospital
Columbia, South Carolina, 29201
Exempla Lutheran Medical Center
Denver, Colorado, 80211
Doylestown Hospital
Doylestown, Pennsylvania, 18901
University of Florida , Division of Vascular Surgery & Endovascular Therapy
Gainesville, Florida, 32610
University of Texas Medical Branch
Galveston, Texas, 77555
Vascular Health Alliance, Greenville Hospital System
Greenville, South Carolina, 29605
St Peters Hospital
Helena, Montana, 59601
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, 83401
Lancaster General Hospital
Lancaster, Pennsylvania, 17601
University Of Kentucky , Vascular and Endovascular Divison
Lexington, Kentucky, 40506
Medical Center of Central Georgia
Macon, Georgia, 31201
West Virginia University Healthcare
Morgantown, West Virginia, 26505
Intermountain Medical Center
Murray, Utah, 84157
Tuoro Infirmary
New Orleans, Louisiana, 70115
Brooklyn Hospital
New York, New York, 11201
University of Pittsburgh School of Medicine Division of Vascular Surgery
Pittsburgh, Pennsylvania, 15213
University Of Rochester Medical Center
Rochester, New York, 14642
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
Bayfront Medical Center
St. Petersburg, Florida, 33701
Stony Brook University Medical Center, Vein Clinic
Stony Brook, New York, 11794
Jobst Vascular Institute
Toledo, Ohio, 43601
Avera Sacred Heart Hospital
Yankton, South Dakota, 57078
About this study
Official title: IVC Filter Study to Monitor and Measure Patients Outcomes Through Standardized Collection and Analysis of Clinical Information
Inferior vena cava (IVC) filter is an important therapeutic device used in the management of venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation therapy. While there has been significant increase in the use of filters , unfortunately there are no standardized collection of data to track, compare outcomes, report safety and efficacy.
Read the detailed description
The registry is a multi-institutional bioinformatics database for the collection of data relevant to Inferior vena cava filters. Participating study centers may enroll patients and enter data in the web-based registry that include demographics, clinical features, management details and follow-up up to 48 months.
The purpose of this study is to improve our understanding of the retrieval rate, long term safety and efficacy on IVC filters placed in North America.
- Conditions
- Venous Thrombo-embolism
- Keywords
- VTE, Inferior vena cava, Venous thrombo-embolism, Outcome data, IVC Filters
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrity of IVC Filter 12 months post placement
Measured: 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thrombo-embolismStudies 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
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Venous Forum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brajesh K Lal, Study chair, University of Maryland Medical Center,BaltimoreJohn E. Rectenwald, Principal investigator, University of MichiganUchenna N Onyeachom, Study director, American Venous Forum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367184
- Sponsor's protocol ID
- AVR-IVC-01
- Status last verified
- Jun 2013
- First submitted
- 3 Jun 2011
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVC Filter Study to Monitor and Measure Patients Outcomes Through Standardized Collection and Analysis of Clinical Information
- ClinicalTrials.gov ID
- NCT01367184
- Acronym / sponsor ID
- AVR-IVC-01
- Conditions
- Venous Thrombo-embolism
- Keywords
- VTE, Inferior vena cava, Venous thrombo-embolism, Outcome data, IVC Filters
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- American Venous ForumUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 7 Jun 2011 (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.
Inferior vena cava (IVC) filter is an important therapeutic device used in the management of venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation therapy. While there has been significant increase in the use of filters , unfortunately there are no standardized collection of data to track, compare outcomes, report safety and efficacy.
Detailed description
The registry is a multi-institutional bioinformatics database for the collection of data relevant to Inferior vena cava filters. Participating study centers may enroll patients and enter data in the web-based registry that include demographics, clinical features, management details and follow-up up to 48 months.
The purpose of this study is to improve our understanding of the retrieval rate, long term safety and efficacy on IVC filters placed in North America.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- No specific criteria. Data from anyone who underwent IVC Filter Placement/Retrieval will be eligible
Key inclusion criteria (1 listed)
- Data obtained in line with good clinical practice,applicable laws and regulation
Key exclusion criteria (0 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
Integrity of IVC Filter 12 months post placement
Time frame: 48 Months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Related InfoLink provided by the sponsor.
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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.
Brajesh K Lal study chair
University of Maryland Medical Center,Baltimore
John E. Rectenwald principal investigator
University of Michigan
Uchenna N Onyeachom study director
American Venous Forum
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombo-embolism, run by American Venous Forum at 27 sites 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 0 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: stopped early, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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?
The study was stopped early. Results are not available in the source record.
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?
Integrity of IVC Filter 12 months post placement (time frame: 48 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 21 Jun 2013.