Iliac AneurysmNCT01055275
Cook Iliac Branch Graft Post-market Registry
An observational study of Iliac Aneurysm and Aortic Aneurysm, run by Cook Group Incorporated at 1 site in Spain.
Trial summary
The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iliac Aneurysm, Aortic Aneurysm
- What is being tested?
- Implantation with a Cook Iliac Branch Graft
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- Sep 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 Cook Iliac Branch Graft.
Who may be able to join
- CE-Marked Cook Iliac Branch Graft (e.g., Zenith® Branch Endovascular Graft-Iliac Bifurcation, Zenith® Helical Branch Endovascular Graft)
- Registry data are de-identified with respect to patient.
Who cannot join
- Patient for whom this device would not normally be considered standard of care.
Trial locations and contacts
1 site in 1 country.
About this study
The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.
- Conditions
- Iliac Aneurysm, Aortic Aneurysm
- Being tested
- Implantation with a Cook Iliac Branch Graft
- Keywords
- iliac aneurysm, aortic aneurysm, endovascular grafts
- Medical subject headings
- Iliac Aneurysm, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation with a Cook Iliac Branch GraftDevice
Treatment of an aortic, aorto-iliac or iliac aneurysm with a CE-marked Cook Iliac Branch Graft.
| Study group | Role | What they receive |
|---|---|---|
| Cook Iliac Branch Graft | Patients implanted with a Cook Iliac Branch Graft Receives: Device: Implantation with a Cook Iliac Branch Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal iliac artery patency
Measured: 1 year
Aneurysm Exclusion
Measured: 1 year
Secondary outcomes (5)
Death
Measured: 1 year
Conversion
Measured: 1 year
Rupture
Measured: 1 year
Success Measures
Measured: 1 year
Major Complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Riambau, MD, PhD, Principal investigator, Hospital Clinic, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055275
- Sponsor's protocol ID
- 09-016
- Status last verified
- Jun 2013
- First submitted
- 22 Jan 2010
- Last updated
- 20 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cook Iliac Branch Graft Post-market Registry
- ClinicalTrials.gov ID
- NCT01055275
- Acronym / sponsor ID
- 09-016
- Conditions
- Iliac Aneurysm, Aortic Aneurysm
- Keywords
- iliac aneurysm, aortic aneurysm, endovascular grafts
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to low enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Jan 2010 (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.
The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cook Iliac Branch Graft | – | Device: Implantation with a Cook Iliac Branch GraftPatients implanted with a Cook Iliac Branch Graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with a Cook Iliac Branch Graft.
Key inclusion criteria (2 listed)
- CE-Marked Cook Iliac Branch Graft (e.g., Zenith® Branch Endovascular Graft-Iliac Bifurcation, Zenith® Helical Branch Endovascular Graft)
- Registry data are de-identified with respect to patient.
Key exclusion criteria (1 listed)
- Patient 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 |
|---|---|---|
| Implantation with a Cook Iliac Branch GraftTreatment of an aortic, aorto-iliac or iliac aneurysm with a CE-marked Cook Iliac Branch Graft. | Device | Cook Iliac Branch Graft |
Primary outcome
Internal iliac artery patency
Time frame: 1 year
Aneurysm Exclusion
Time frame: 1 year
5 secondary outcomes
Death
Time frame: 1 year
Conversion
Time frame: 1 year
Rupture
Time frame: 1 year
Success Measures
Time frame: 1 year
Major Complications
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Terminated due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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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.
Vincent Riambau, MD, PhD principal investigator
Hospital Clinic, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Aneurysm and Aortic Aneurysm, run by Cook Group Incorporated at 1 site in Spain.
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 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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: Terminated due to low enrollment.). 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?
Internal iliac artery patency (time frame: 1 year). The study lists 2 primary outcomes in all. 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 20 Jun 2013.