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Xtract™ Aspiration Catheter Registry Study
This study has been completed.
Sponsored by: 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

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Xtract™ Aspiration Catheter Registry Study

Further study details as provided by Lumen Biomedical:

Primary Outcome Measures:
  • The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.

Study Start Date: August 2006
Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion
  • Angiographic evidence of thrombus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349570

Locations
New Zealand
Auckland City Hospital
Auckland, New Zealand
ChristChurch Hospital
ChristChurch, New Zealand
Sponsors and Collaborators
Lumen Biomedical
Investigators
Principal Investigator: Mark Webster, MD Auckland City Hospital
  More Information

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

Keywords provided by Lumen Biomedical:
thrombus
aspiration catheter

Study placed in the following topic categories:
Embolism and Thrombosis
Embolism
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009