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

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 1786

Contacts and Locations

• Study Contact: Name: Uchenna N Onyeachom; Email: uonyeachom@hvori.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Filter retrieval rate	24 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Absence of major adverse event	24 Months

Collaborators and Investigators

• Sponsor: Heart and Vascular Outcomes Research Institute
• Investigators: Study Director: Uchenna Onyeachom, Heart and Vascular Outcomes Research Institute; Principal Investigator: John Rectenwald, MD, University of Michigan Health System, Ann Arbor

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: June 7, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Inferior Vena Cava
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: PC14-0610-002