Xtract™ Aspiration Catheter Registry Study

Lumen Biomedical

Status: Completed

Conditions: Fresh Soft Emboli or Thrombi in the Arteries.

Treatments: Device: Xtract Aspiration Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349570

90-1027

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)