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RexMedical- Option* Vena Cava Filter IDE Study

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intravascular Filter Device
Sponsored by
Rex Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Embolism focused on measuring increased risk for PE require caval interruption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peninsula Surgical Specialists Medical Group, Inc.
  • Christiana Care Health System
  • George Washington University
  • Miami Cardiac & Vascular Institute
  • Northwestern Memorial Hospital
  • Indiana University School of Medicine
  • Brigham and Women's Hospital
  • New York Presbyterian Hospital/Columbia
  • OHSU
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intravascular Filter Device

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 18, 2007
Last Updated
August 4, 2010
Sponsor
Rex Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00488865
Brief Title
RexMedical- Option* Vena Cava Filter IDE Study
Official Title
RexMedical- Option* Vena Cava Filter IDE Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rex Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
increased risk for PE require caval interruption

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravascular Filter Device
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Intravascular Filter Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Success
Description
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.
Time Frame
up to 180 days
Title
Percentage of Participants With Retrieval Clinical Success
Description
Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.
Time Frame
upto 175 days
Secondary Outcome Measure Information:
Title
Placement Technical Success
Description
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.
Time Frame
Immediately post placement procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peninsula Surgical Specialists Medical Group, Inc.
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Miami Cardiac & Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
New York Presbyterian Hospital/Columbia
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20598570
Citation
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.
Results Reference
derived

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RexMedical- Option* Vena Cava Filter IDE Study

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