NCT00349570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

First QC Date

July 5, 2006

Last Update Submit

October 20, 2008

Conditions

Fresh Soft Emboli or Thrombi in the Arteries.

Keywords

thrombusaspiration catheter

Outcome Measures

Primary Outcomes (1)

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

Interventions

Xtract Aspiration CatheterDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Auckland City Hospital

Auckland, New Zealand

Location

ChristChurch Hospital

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Mark Webster, MD

    Auckland City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 7, 2006

Study Start

August 1, 2006

Study Completion

March 1, 2008

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

NZ(2)