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Sponsored by: |
Crux Biomedical |
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Information provided by: | Crux Biomedical |
ClinicalTrials.gov Identifier: | NCT00605332 |
This is an open label, non-randomized, prospective, multicenter study.
Condition | Intervention | Phase |
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Pulmonary Embolism |
Device: inferior vena cava filter |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System - ("Retrieve") |
Estimated Enrollment: | 104 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Investigative Device (Crux Biomedical IVC Filter) will be evaluated for its ability to capture thrombus for the prevention of pulmonary embolism.
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Device: inferior vena cava filter
Crux Biomedical IVC Filter
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients for this study must meet the following inclusion criteria to be eligible for enrollment:
Patient is considered a candidate for the IVCF under one of the following indications:
Exclusion Criteria:
Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
The patient has one of the following conditions:
United States, California | |
St. Joseph's Hospital of Orange | Recruiting |
Orange, California, United States, 92868 | |
Contact: Doreen Robinson, RN 714-560-4450 doreen@vascularspecialistsoc.com | |
Principal Investigator: Kurt Openshaw, MD | |
Harbor / UCLA Medical Center | Recruiting |
Torrance, California, United States, 90509 | |
Contact: Abilene Lobue, RN 310-222-5249 alobue@ladhs.org | |
Principal Investigator: Rod White, MD | |
UC Davis Heart Center | Not yet recruiting |
Sacramento, California, United States, 95817 | |
Contact: Janine Carlson, RN 916-734-2197 janine.carlson@ucdmc.ucdavis.edu | |
Contact: Kori Harder, RN 916-703-7073 kori.harder@ucdmc.ucdavis.edu | |
Principal Investigator: John R. Laird, MD | |
United States, Connecticut | |
Hartford Hospital | Not yet recruiting |
Hartford, Connecticut, United States, 06102 | |
Contact: Anna Lynne Hosig, CCRP 860-545-1005 LHOSIG@harthosp.org | |
Principal Investigator: M. Hallisey, MD | |
United States, Georgia | |
Atlanta Medical Center | Recruiting |
Atlanta, Georgia, United States, 30312 | |
Contact: Carol Daigle 040-524-0095 cdaigle@mindspring.com | |
Principal Investigator: David Rosenthal, MD | |
United States, Illinois | |
St. Francis | Not yet recruiting |
Peoria, Illinois, United States, 61637 | |
Contact: Stephanie Gilbert 309-655-7653 smccarty@cirarad.com | |
Principal Investigator: H. Bob Smouse, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Kerri Briesmiester, BBA 734-936-8874 kbries@med.umich.edu | |
Principal Investigator: Kyung Cho, MD | |
United States, Missouri | |
Washington University Barnes Jewish | Not yet recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Patty Neiders, RN 314-362-6409 nietersp@wudosis.wustl.edu | |
Principal Investigator: Luis Sanchez, MD | |
United States, North Carolina | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact: Dianne Glover, RN 919-843-1278 dianne_Glover@med.unc.edu | |
Principal Investigator: Robert Mendes, MD | |
United States, Ohio | |
Jobst Vascular | Recruiting |
Toledo, Ohio, United States, 43606 | |
Contact: Sue Shuman 419-291-2060 susan.shuman@promedica.org | |
Contact: Jacki Stedman 419-291-3598 Jacki.Stedman@ProMedica.org | |
Principal Investigator: Tony Comerota, MD | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Grace Cheah 216-444-9338 CHEAHG@ccf.org | |
Principal Investigator: Mark Sands, MD | |
United States, Virginia | |
Inova Fairfax Hospital | Not yet recruiting |
Fairfax, Virginia, United States, 22031 | |
Contact: Sally Keyte, RN 703-776-2995 Sally.Keyte@inova.org | |
Principal Investigator: Alain Drooz, MD |
Principal Investigator: | David Rosenthal, MD | Atlanta Vascular Specialists |
Study Director: | Mel Schatz | Crux Biomedical |
Study Director: | Roberta Hines | Northwest Clinical Research Group |
Responsible Party: | Crux Biomedical ( Mel Schatz / President & CEO ) |
Study ID Numbers: | Retrieve, G070035 |
Study First Received: | January 2, 2008 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00605332 |
Health Authority: | United States: Food and Drug Administration |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism |
Lung Diseases Vascular Diseases Thrombosis |
Cardiovascular Diseases |