Xtractâ„¢ Aspiration Catheter Registry Study
NCT00349570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL
Last updated 2008-10-21
Summary
Intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous coronary and other vascular interventional techniques. The Xtractâ„¢ 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.
Conditions
- Fresh Soft Emboli or Thrombi in the Arteries.
Interventions
- DEVICE
-
Xtract Aspiration Catheter
Sponsors & Collaborators
-
Lumen Biomedical
lead INDUSTRY
Principal Investigators
-
Mark Webster, MD · Auckland City Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-08-31
- Completion
- 2008-03-31
Countries
- New Zealand
Study Locations
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