NCT00488865

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 5, 2010

Completed
Last Updated

August 10, 2010

Status Verified

August 1, 2010

Enrollment Period

2.2 years

First QC Date

June 18, 2007

Results QC Date

May 3, 2010

Last Update Submit

August 4, 2010

Conditions

Pulmonary Embolism

Keywords

increased risk for PE require caval interruption

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Placement Technical Success

    Immediately post placement procedure

Study Arms (1)

Intravascular Filter Device

OTHER
Device: Intravascular Filter Device

Interventions

Intravascular Filter DeviceDEVICE

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.

Intravascular Filter Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is at least 18 years of age
  • Patient requires temporary or permanent caval interruption

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Peninsula Surgical Specialists Medical Group, Inc.

Burlingame, California, 94010, United States

Location

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Miami Cardiac & Vascular Institute

Miami, Florida, 33176, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

New York Presbyterian Hospital/Columbia

New York, New York, 10032, United States

Location

OHSU

Portland, Oregon, 97201, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Johnson MS, Nemcek AA Jr, Benenati JF, Baumann DS, Dolmatch BL, Kaufman JA, Garcia MJ, Stecker MS, Venbrux AC, Haskal ZJ, Avelar RL. The safety and effectiveness of the retrievable option inferior vena cava filter: a United States prospective multicenter clinical study. J Vasc Interv Radiol. 2010 Aug;21(8):1173-84. doi: 10.1016/j.jvir.2010.04.004. Epub 2010 Jul 3.

    PMID: 20598570DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
James Bressler
Organization
Rex Medical
ebressler@rexmedical.com
610-940-0665

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

August 10, 2010

Results First Posted

August 5, 2010

Record last verified: 2010-08

Locations

US(10)