Xtract™ Aspiration Catheter Registry Study

Fresh Soft Emboli or Thrombi in the Arteries. Clinical Trial

Official title:

Xtract™ Aspiration Catheter Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349570
• Other study ID #: 90-1027
• Status: Completed
• Phase: N/A
• First received: July 5, 2006
• Last updated: October 20, 2008
• Start date: August 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2008
• Source: Lumen Biomedical
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion

• Angiographic evidence of thrombus.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fresh Soft Emboli or Thrombi in the Arteries.

Intervention

Device:
• Xtract Aspiration Catheter

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland
New Zealand	ChristChurch Hospital	ChristChurch

Sponsors (1)

Lead Sponsor	Collaborator
Lumen Biomedical

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.