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Sponsored by: |
Lumen Biomedical |
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Information provided by: | Lumen Biomedical |
ClinicalTrials.gov Identifier: | NCT00349570 |
Intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous coronary and other vascular interventional techniques. The Xtract™ Aspiration Catheter is a single use device designed to remove fresh, soft emboli and thrombi from the arterial system using standard catheter techniques, compatible with 6 Fr guide catheters and 0.014 guidewires. The purpose of this registry study is to validate the design and demonstrate the performance of the Xtract Aspiration Catheter as a thrombectomy catheter during percutaneous intervention of vessels in the arterial system. Subjects will be enrolled during percutaneous intervention when the Interventional Physician decides a thrombectomy catheter is needed to remove thrombus during the procedure.
Condition | Intervention |
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Fresh Soft Emboli or Thrombi in the Arteries. |
Device: Xtract Aspiration Catheter |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Xtract™ Aspiration Catheter Registry Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
New Zealand | |
Auckland City Hospital | |
Auckland, New Zealand | |
ChristChurch Hospital | |
ChristChurch, New Zealand |
Principal Investigator: | Mark Webster, MD | Auckland City Hospital |
Study ID Numbers: | 90-1027 |
Study First Received: | July 5, 2006 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00349570 |
Health Authority: | New Zealand: Ministry of Health |
thrombus aspiration catheter |
Embolism and Thrombosis Embolism Vascular Diseases Thrombosis |
Cardiovascular Diseases |