Fresh Soft Emboli or Thrombi in the Arteries.NCT00349570
Xtract™ Aspiration Catheter Registry Study
A study testing Xtract Aspiration Catheter in people with Fresh Soft Emboli or Thrombi in the Arteries., run by Lumen Biomedical at 2 sites in New Zealand.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fresh Soft Emboli or Thrombi in the Arteries.
- What is being tested?
- Xtract Aspiration Catheter
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 2 sitesNew Zealand
- Study dates
- Aug 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion
- Angiographic evidence of thrombus.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland City Hospital
Auckland
ChristChurch Hospital
Christchurch
About this 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.
- Being tested
- Xtract Aspiration Catheter
- Keywords
- thrombus, aspiration catheter
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xtract Aspiration CatheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startAug 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fresh Soft Emboli or Thrombi in the Arteries.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Lumen Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Webster, MD, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349570
- Sponsor's protocol ID
- 90-1027
- Status last verified
- Oct 2008
- First submitted
- 5 Jul 2006
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xtract™ Aspiration Catheter Registry Study
- ClinicalTrials.gov ID
- NCT00349570
- Acronym / sponsor ID
- 90-1027
- Keywords
- thrombus, aspiration catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Lumen BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Mar 2008 (actual)
- First posted
- 7 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion
- Angiographic evidence of thrombus.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xtract Aspiration Catheter | Device | – |
Primary outcome
The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Webster, MD principal investigator
Auckland City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xtract Aspiration Catheter in people with Fresh Soft Emboli or Thrombi in the Arteries., run by Lumen Biomedical at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.