Venous Thromboembolism,iRetrieveNCT02160964
Using a Novel Algorithm to Improve the Retrieval Rate of Inferior Vena Cava Filters (iRetrieve Study)
An observational study of Venous Thromboembolism, and Pulmonary Embolism,, run by Heart and Vascular Outcomes Research Institute.
Trial summary
Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have been made in the filter design to resolve problems of structural integrity and increase the ability to remove the filter after longer periods of time.The FDA issued a communication in August 2010 advising physicians to remove… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Thromboembolism,, Pulmonary Embolism,, Deep Vein Thrombosis,
- How many people
- 1,786 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2017
- 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: Participating study centers will enroll patients and enter data in the web-based platform that include demographics, clinical features, and clinical pathway
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
No sites are listed yet.
Uchenna N Onyeachom contact
About this study
Official title: A Prospective Multi-center Study Using a Novel Algorithm to Improve the Retrieval Rate of Inferior Vena Cava Filters Placed Across the US
Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have been made in the filter design to resolve problems of structural integrity and increase the ability to remove the filter after longer periods of time.The FDA issued a communication in August 2010 advising physicians to remove retrievable filters whenever possible and updated that letter again in May 2014 due to concerns that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
Read the detailed description
Several studies have shown that approximately 80% to 85% of optional IVC filters are never retrieved. The successful removal of retrievable filters requires diligent patient follow-up and interdepartmental cooperation, and even so, successful removal is not always possible. American College of Chest Physicians (ACCP) guidelines for IVCF placement indications advocates a close, structured follow-up of retrievable IVCFs to improve filter retrieval rates.
Using a retrieval algorithm and pathway program, a score will trigger a secure email and text messages sent to both physician and patient at different timelines, for follow up so as to retrieve filter placed.
- Keywords
- Inferior Vena Cava
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter retrieval rate
Measured: 24 Months
Secondary outcomes (1)
Absence of major adverse event
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startMay 2015
- Primary completionJul 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism,Studies 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
- 1,786 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Vascular Outcomes Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uchenna Onyeachom, Study director, Heart and Vascular Outcomes Research InstituteJohn Rectenwald, MD, Principal investigator, University Of Michigan Health System, Ann Arbor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160964
- Sponsor's protocol ID
- PC14-0610-002
- Acronym
- iRetrieve
- Status last verified
- Mar 2015
- First submitted
- 7 Jun 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
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 Prospective Multi-center Study Using a Novel Algorithm to Improve the Retrieval Rate of Inferior Vena Cava Filters Placed Across the US
- ClinicalTrials.gov ID
- NCT02160964
- Acronym / sponsor ID
- iRetrieve / PC14-0610-002
- Keywords
- Inferior Vena Cava
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,786 participants (estimated)
- Lead sponsor
- Heart and Vascular Outcomes Research InstituteUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 11 Jun 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.
Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have been made in the filter design to resolve problems of structural integrity and increase the ability to remove the filter after longer periods of time.The FDA issued a communication in August 2010 advising physicians to remove retrievable filters whenever possible and updated that letter again in May 2014 due to concerns that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
Detailed description
Several studies have shown that approximately 80% to 85% of optional IVC filters are never retrieved. The successful removal of retrievable filters requires diligent patient follow-up and interdepartmental cooperation, and even so, successful removal is not always possible. American College of Chest Physicians (ACCP) guidelines for IVCF placement indications advocates a close, structured follow-up of retrievable IVCFs to improve filter retrieval rates.
Using a retrieval algorithm and pathway program, a score will trigger a secure email and text messages sent to both physician and patient at different timelines, for follow up so as to retrieve filter placed.
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
- Participating study centers will enroll patients and enter data in the web-based platform that include demographics, clinical features, and clinical pathway
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
Filter retrieval rate
Time frame: 24 Months
1 secondary outcome
Absence of major adverse event
Time frame: 24 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 contact
Uchenna Onyeachom study director
Heart and Vascular Outcomes Research Institute
John Rectenwald, MD principal investigator
University Of Michigan Health System, Ann Arbor
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, and Pulmonary Embolism,, run by Heart and Vascular Outcomes Research Institute.
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.
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 (uonyeachom@hvori.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter retrieval rate (time frame: 24 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.