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Xtractâ„¢ Aspiration Catheter Registry Study

NCT ID: NCT00349570

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-03-31

Brief Summary

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Intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous coronary and other vascular interventional techniques. The Xtractâ„¢ 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

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Conditions

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Fresh Soft Emboli or Thrombi in the Arteries.

Keywords

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thrombus aspiration catheter

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Xtract Aspiration Catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lumen Biomedical

INDUSTRY

Sponsor Role lead

Principal Investigators

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Mark Webster, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Locations

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Auckland City Hospital

Auckland, , New Zealand

Site Status

ChristChurch Hospital

Christchurch, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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90-1027

Identifier Type: -

Identifier Source: org_study_id