Evaluation of the Short and Long Term Performance and Clinical Outcomes of the Crux Vena Cava Filter System

Volcano Crux Vena Cava Filter Registry

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.

Study Overview

• Status: Withdrawn
• Conditions: Deep Vein Thrombosis; Venous Thromboembolism; Pulmonary Embolism

Detailed Description

The Crux VCF Registry is a non-randomized clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux VCF System. The registry includes consecutive patients treated with the Crux VCF in a post-market (commercial) setting with data collection at the implant procedure through 2 years post implant or to filter retrieval, whichever comes first. Patients may also be enrolled (roll-in) from a previous Crux VCF implant within the previous 6 months. Follow up assessment will be performed at 6, 12 and 24 months post-implant and at the time of retrieval, if performed.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Vascular Surgery
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Rex Healthcare
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Turkey Creek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. The patient is >18 years of age.
2. Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent.
3. Scheduled for and receives a Crux VCF implant or;
4. Have previously had a Crux VCF implanted within the previous 6 months.

Exclusion Criteria:

1. Patient is scheduled for filter implant, but did not have a Crux VCF filter implanted due to anatomical exclusions or technical failures.
2. Patients unwilling or unable to comply with the protocol and provide informed consent.
3. 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)
4. Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Volcano Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• 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: 140203