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| Sponsor: | Lumen Biomedical |
|---|---|
| Information provided by: | Lumen Biomedical |
| ClinicalTrials.gov Identifier: | NCT00349570 |
Purpose
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 |
|---|---|
|
Fresh Soft Emboli or Thrombi in the Arteries. |
Device: Xtract Aspiration Catheter |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Xtract™ Aspiration Catheter Registry Study |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| New Zealand | |
| Auckland City Hospital | |
| Auckland, New Zealand | |
| ChristChurch Hospital | |
| ChristChurch, New Zealand | |
| Principal Investigator: | Mark Webster, MD | Auckland City Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00349570 History of Changes |
| Other Study ID Numbers: | 90-1027 |
| Study First Received: | July 5, 2006 |
| Last Updated: | October 20, 2008 |
| Health Authority: | New Zealand: Ministry of Health |
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thrombus aspiration catheter |
|
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |