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

Deep Vein Thrombosis, Clinical Trial

— iRetrieve  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02160964
• Other study ID #: PC14-0610-002
• Status: Not yet recruiting
• Phase: N/A
• First received: June 7, 2014
• Last updated: March 18, 2015
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2015
• Source: Heart and Vascular Outcomes Research Institute
• Contact: Uchenna N Onyeachom
• Email: uonyeachom[@]hvori.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1786
• Est. completion date: January 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Vein Thrombosis,
• Pulmonary Embolism
• Pulmonary Embolism,
• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism,
• Venous Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Vascular Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Filter retrieval rate		24 Months	No
Secondary	Absence of major adverse event		24 Months	Yes