RexMedical- Option* Vena Cava Filter IDE Study

Pulmonary Embolism Clinical Trial

Official title:

RexMedical- Option* Vena Cava Filter IDE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488865
• Other study ID #: REX-US-2006-001
• Status: Completed
• Phase: N/A
• First received: June 18, 2007
• Last updated: August 4, 2010
• Start date: October 2006
• Est. completion date: June 2009

Study information

• Verified date: August 2010
• Source: Rex Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of the RexMedical Option* Vena Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and require caval interruption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Patient is at least 18 years of age

• Patient requires temporary or permanent caval interruption

Key Exclusion Criteria:

• Patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant

• Patient is currently enrolled in another investigational device or drug trial

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pulmonary Embolism

Intervention

Device:
• Intravascular Filter Device
Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Peninsula Surgical Specialists Medical Group, Inc.	Burlingame	California
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Miami Cardiac & Vascular Institute	Miami	Florida
United States	New York Presbyterian Hospital/Columbia	New York	New York
United States	Christiana Care Health System	Newark	Delaware
United States	OHSU	Portland	Oregon
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Rex Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Clinical Success	Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.	up to 180 days	Yes
Primary	Percentage of Participants With Retrieval Clinical Success	Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.	upto 175 days	Yes
Secondary	Placement Technical Success	Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.	Immediately post placement procedure	Yes