Abdominal Aortic AneurysmNCT01424267
Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry
An observational study of Abdominal Aortic Aneurysm and Aorto-iliac Aneurysm, run by Cook Group Incorporated at 15 sites in 7 countries.
Trial summary
A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm
- What is being tested?
- Zenith® Low Profile AAA Endovascular Graft
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Jul 2010to Aug 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients implanted with a CE-Marked Zenith® Low Profile AAA Endovascular Graft
Who may be able to join
- Patient is implanted with Zenith® Low Profile AAA Endovascular Graft
Who cannot join
- Patients for whom this device would not normally be considered standard of care.
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
United Kingdom5 sites
Guy's and St. Thomas' Hospital
London
St. Mary's Hospital
London
Manchester Royal Informary
Manchester
Freeman Hospital
Newcastle upon Tyne
Royal Gwent Hospital
Wales
Germany3 sites
UHZ Hamburg GmbH (Eppendorf University Hospital)
Hamburg
Klinikum rechts der Isar (RDI Munich)
Munich
Klinikum Nürnberg Süd
Nuremberg
Italy2 sites
Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara
Modena
Azoemda ospedaliera San Camillo Forlanini
Rome
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven
Maastricht University Medical Center
Maastricht
About this study
Official title: Zenith® LP AAA Endovascular Graft Post-Market Registry
A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.
- Conditions
- Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm
- Being tested
- Zenith® Low Profile AAA Endovascular Graft
- Keywords
- low profile, endovascular graft, endovascular procedure, aortic aneurysm, abdominal aortic aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith® Low Profile AAA Endovascular GraftDevice
Treatment of an abdominal aortic or aorto-iliac aneurysm with the CE-marked Zenith(R) Low Profile AAA Endovascular Graft.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Device: Zenith® Low Profile AAA Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft patency and aneurysm exclusion
Measured: during (day 1) and after implantation through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJul 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: The registry was discontinued due to significant resources required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424267
- Sponsor's protocol ID
- 10-006
- Status last verified
- Oct 2012
- First submitted
- 23 Aug 2011
- Last updated
- 11 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® LP AAA Endovascular Graft Post-Market Registry
- ClinicalTrials.gov ID
- NCT01424267
- Acronym / sponsor ID
- 10-006
- Conditions
- Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm
- Keywords
- low profile, endovascular graft, endovascular procedure, aortic aneurysm, abdominal aortic aneurysm
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The registry was discontinued due to significant resources required.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Aug 2011 (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.
A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Zenith® Low Profile AAA Endovascular Graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with a CE-Marked Zenith® Low Profile AAA Endovascular Graft
Key inclusion criteria (1 listed)
- Patient is implanted with Zenith® Low Profile AAA Endovascular Graft
Key exclusion criteria (1 listed)
- Patients for whom this device would not normally be considered standard of care.
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 |
|---|---|---|
| Zenith® Low Profile AAA Endovascular GraftTreatment of an abdominal aortic or aorto-iliac aneurysm with the CE-marked Zenith(R) Low Profile AAA Endovascular Graft. | Device | 1 |
Primary outcome
graft patency and aneurysm exclusion
Time frame: during (day 1) and after implantation through 12 months
Results and safety
The study was stopped early (reason given: The registry was discontinued due to significant resources required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Aorto-iliac Aneurysm, run by Cook Group Incorporated at 15 sites in 7 countries.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, Germany, Italy, Netherlands, Austria and 2 more countries. 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 was stopped early (reason given: The registry was discontinued due to significant resources required.). Results are not available in the source record.
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?
graft patency and aneurysm exclusion (time frame: during (day 1) and after implantation through 12 months). 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 11 Oct 2012.