Back to resultsXtract™ Aspiration Catheter Registry Study
Primary Purpose
Fresh Soft Emboli or Thrombi in the Arteries.
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Xtract Aspiration Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Fresh Soft Emboli or Thrombi in the Arteries. focused on measuring thrombus, aspiration catheter
Eligibility Criteria
Inclusion Criteria: Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion Angiographic evidence of thrombus.
Sites / Locations
- Auckland City Hospital
- ChristChurch Hospital
Outcomes
Primary Outcome Measures
The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349570
Brief Title
Xtract™ Aspiration Catheter Registry Study
Official Title
Xtract™ Aspiration Catheter Registry Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lumen Biomedical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fresh Soft Emboli or Thrombi in the Arteries.
Keywords
thrombus, aspiration catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Xtract Aspiration Catheter
Primary Outcome Measure Information:
Title
The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion
Angiographic evidence of thrombus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Webster, MD
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
ChristChurch Hospital
City
ChristChurch
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
Xtract™ Aspiration Catheter Registry Study
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