Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using a Novel Algorithm to Improve the Retrieval Rate of Inferior Vena Cava Filters (iRetrieve Study) (iRetrieve)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160964
Recruitment Status : Unknown
Verified March 2015 by Heart and Vascular Outcomes Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2014
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Heart and Vascular Outcomes Research Institute

Brief 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 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.

Condition or disease
Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis,

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1786 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : January 2017



Primary Outcome Measures :
  1. Filter retrieval rate [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. Absence of major adverse event [ Time Frame: 24 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participating study centers will enroll patients and enter data in the web-based platform that include demographics, clinical features, and clinical pathway
Criteria

Inclusion Criteria:

  • Data obtained in line with good clinical practice, applicable laws and regulation

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160964


Contacts
Layout table for location contacts
Contact: Uchenna N Onyeachom uonyeachom@hvori.org

Sponsors and Collaborators
Heart and Vascular Outcomes Research Institute
Investigators
Layout table for investigator information
Study Director: Uchenna Onyeachom Heart and Vascular Outcomes Research Institute
Principal Investigator: John Rectenwald, MD University Of Michigan Health System, Ann Arbor
Layout table for additonal information
Responsible Party: Heart and Vascular Outcomes Research Institute
ClinicalTrials.gov Identifier: NCT02160964    
Other Study ID Numbers: PC14-0610-002
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Keywords provided by Heart and Vascular Outcomes Research Institute:
Inferior Vena Cava
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases