Study Stopped
An industry-wide, alternative, post-market study has been initiated
Evaluation of the Short and Long Term Performance and Clinical Outcomes of the Crux Vena Cava Filter System
Volcano Crux Vena Cava Filter Registry
1 other identifier
observational
N/A
1 country
3
Brief Summary
The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux Vena Cava Filter System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2016
Typical duration for all trials
3 active sites
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
First Submitted
Initial submission to the registry
April 7, 2015
CompletedFirst Posted
Study publicly available on registry
April 20, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedApril 22, 2016
December 1, 2015
1.3 years
April 7, 2015
April 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Prevention of Pulmonary Embolism
The primary objective is to evaluate the long term clinical outcomes of patients treated with the Crux VCF for the prevention of PE over a two year period or up to filter retrieval, whichever comes first.
2 years
Eligibility Criteria
Patients are eligible for inclusion if they are scheduled for a vena cava filter implant with the Crux VCF System or have had a Crux VCF implanted within the previous 6 months for any of the following situations: 1. Pulmonary thromboembolism when anticoagulation therapy is contraindicated; 2. Failure of anticoagulation therapy in thromboembolic disease; 3. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and 4. Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
You may qualify if:
- The patient is \>18 years of age.
- Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent.
- Scheduled for and receives a Crux VCF implant or;
- Have previously had a Crux VCF implanted within the previous 6 months.
You may not qualify if:
- Patients unwilling or unable to comply with the protocol and provide informed consent.
- Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
- Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Northside Vascular Surgery
Atlanta, Georgia, 30342, United States
Rex Healthcare
Raleigh, North Carolina, 27607, United States
Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2015
First Posted
April 20, 2015
Study Start
January 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2019
Last Updated
April 22, 2016
Record last verified: 2015-12