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OpenTrials
Completed

NCT Number: NCT00349570

Xtract™ Aspiration Catheter Registry Study

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.

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Key information

Conditions

Fresh Soft Emboli or Thrombi in the Arteries. Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auckland City Hospital, Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Xtract Aspiration Catheter

Device

Primary outcomes

  1. The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.

Sponsors and collaborators

Lead sponsor

Lumen Biomedical

Industry

Registry information

Important dates

Study start
2006
Study completion
2008
First posted
Jul 7, 2006
Registry last updated
Oct 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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