Abdominal Aortic AneurysmNCT00196092
Zenith® AAA Endovascular Graft Clinical Study
A study testing Roll-in, Surgical and Standard Risk in people with Abdominal Aortic Aneurysm, run by Cook Group Incorporated.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Roll-in, Surgical and Standard Risk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 819 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Jul 2006
- 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
- Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
- Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
- Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.
Who cannot join
- Patients less than 18 years of age.
- Patient with a life expectancy less than 2 years.
- Patients who are pregnant.
- Patients unwilling to comply with the follow-up schedule.
- Patient inability or refusal to give informed consent.
About this study
The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Roll-in, Surgical, Standard Risk, High Risk, Compassionate Use
- 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.
Roll-inDevice
Proctored entry.
SurgicalDevice
Surgery
Standard RiskDevice
Standard Endovascular repair
High RiskDevice
High Risk Endovascular repair.
Compassionate UseDevice
Endovascular repair for compassionate use patients.
Treatment for femalesDevice
Endovascular repair in female patients
Standard Risk Continued AccessDevice
Continued Access Endovascular repair for standard risk patients.
High Risk Continued AccessDevice
Continued Access Endovascular Repair for High Risk Patients.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Roll-in Receives: Device: Roll-in |
| 2 | Other | Surgical Receives: Device: Surgical |
| 3 | Other | Standard Risk Receives: Device: Standard Risk |
| 4 | Other | High Risk Receives: Device: High Risk |
| 5 | Other | Compassionate Use Receives: Device: Compassionate Use |
| 6 | Other | Treatment for females. Receives: Device: Treatment for females |
| 7 | Other | Standard Risk Continued Access Receives: Device: Standard Risk Continued Access |
| 8 | Other | High Risk Continued Access Receives: Device: High Risk Continued Access |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2000
- Study completionJul 2006
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roy Greenberg, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196092
- Sponsor's protocol ID
- 99-514
- Status last verified
- Dec 2007
- First submitted
- 13 Sep 2005
- Last updated
- 12 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® AAA Endovascular Graft Clinical Study
- ClinicalTrials.gov ID
- NCT00196092
- Acronym / sponsor ID
- 99-514
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 819 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Study completion
- Jul 2006 (actual)
- First posted
- 20 Sep 2005 (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 purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Roll-inRoll-in |
| 2 | Other | Device: SurgicalSurgical |
| 3 | Other | Device: Standard RiskStandard Risk |
| 4 | Other | Device: High RiskHigh Risk |
| 5 | Other | Device: Compassionate UseCompassionate Use |
| 6 | Other | Device: Treatment for femalesTreatment for females. |
| 7 | Other | Device: Standard Risk Continued AccessStandard Risk Continued Access |
| 8 | Other | Device: High Risk Continued AccessHigh Risk Continued Access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
- Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
- Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.
Key exclusion criteria (5 listed)
- Patients less than 18 years of age.
- Patient with a life expectancy less than 2 years.
- Patients who are pregnant.
- Patients unwilling to comply with the follow-up schedule.
- Patient inability or refusal to give informed consent.
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 |
|---|---|---|
| Roll-inProctored entry. | Device | 1 |
| SurgicalSurgery | Device | 2 |
| Standard RiskStandard Endovascular repair | Device | 3 |
| High RiskHigh Risk Endovascular repair. | Device | 4 |
| Compassionate UseEndovascular repair for compassionate use patients. | Device | 5 |
| Treatment for femalesEndovascular repair in female patients | Device | 6 |
| Standard Risk Continued AccessContinued Access Endovascular repair for standard risk patients. | Device | 7 |
| High Risk Continued AccessContinued Access Endovascular Repair for High Risk Patients. | Device | 8 |
Primary outcome
Not reported in the source record.
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 12 Mar 2015.
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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.
Roy Greenberg, M.D. principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Roll-in, Surgical and Standard Risk in people with Abdominal Aortic Aneurysm, run by Cook Group Incorporated.
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 3 inclusion and 5 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 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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 12 Mar 2015.