Xtract™ Aspiration Catheter Registry Study

Not Applicable

Completed

• Conditions: Fresh Soft Emboli or Thrombi in the Arteries.

• Registration Number: NCT00349570
• Lead Sponsor: Lumen Biomedical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-07
• Study Start: 2006-08
• Study Completion: 2008-03
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-20
• Last Update Posted: 2008-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion
• Angiographic evidence of thrombus.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.

Trial Locations

Locations (2)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

ChristChurch Hospital; 🇳🇿 ChristChurch, New Zealand