Abdominal AorticNCT03061825
Zenith Alpha™ Abdominal Endovascular Graft
An observational study of Abdominal Aortic and Aorto-iliac Aneurysm, run by Cook Research Incorporated at 5 sites in Canada.
Trial summary
The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic, Aorto-iliac Aneurysm
- What is being tested?
- Zenith Alpha™ Abdominal Endovascular Graft
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesCanada
- Study dates
- 24 May 2017to 6 Jan 2021
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential study patients with abdominal aortic or aorto-iliac aneurysm will be "screened " at the hospital.
Who may be able to join
- A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft
Who cannot join
- Life expectancy less than (<) 2 years
- Inability or refusal to give informed consent by the patient or legally authorized representative
- Unwilling or unable to comply with the study follow-up
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Nova Soctia Health Authority
Halifax, Nova Scotia, B3H3A7
Hamilton General Hospital
Hamilton, Ontario, L8L2X2
London Health Sciences Center
London, Ontario, N6A 4G5
Toronto General Hospital
Toronto, Ontario, M5G 1X6
Vancouver Hospital and Health Science Center
Vancouver, British Columbia, V6T 2B5
About this study
Official title: Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft
The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.
- Conditions
- Abdominal Aortic, Aorto-iliac Aneurysm
- Being tested
- Zenith Alpha™ Abdominal Endovascular Graft
- Keywords
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Iliac Aneurysm, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
- Medical subject headings
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Iliac Aneurysm, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith Alpha™ Abdominal Endovascular GraftDevice
Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success
Technical success (successful introduction and deployment of the device in the absence of surgical conversion or mortality) plus freedom from the following: abdominal aneurysm rupture, conversion, Type I or III endoleak, graft limb occlusion and abdominal aneurysm size increase > 5 mm.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start24 May 2017
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal AorticStudies 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
- 100 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Forbes, MD, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061825
- Sponsor's protocol ID
- 15-10
- Status last verified
- Jan 2021
- First submitted
- 20 Feb 2017
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lindsay TF, Harlock J, Herman C, Chen J, Power A, Saunders AT. A Canadian postmarket study of the Zenith Alpha Abdominal Endovascular Graft. J Vasc Surg. 2025 May;81(5):1058-1066.e1. doi: 10.1016/j.jvs.2025.01.196. Epub 2025 Jan 30.
PubMed 39892792
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft
- ClinicalTrials.gov ID
- NCT03061825
- Acronym / sponsor ID
- 15-10
- Conditions
- Abdominal Aortic, Aorto-iliac Aneurysm
- Keywords
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Iliac Aneurysm, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 24 May 2017 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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 clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study patients with abdominal aortic or aorto-iliac aneurysm will be "screened " at the hospital.
Key inclusion criteria (1 listed)
- A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft
Key exclusion criteria (3 listed)
- Life expectancy less than (<) 2 years
- Inability or refusal to give informed consent by the patient or legally authorized representative
- Unwilling or unable to comply with the study follow-up
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 Alpha™ Abdominal Endovascular GraftZenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm. | Device | – |
Primary outcome
Device Success
Time frame: 2 years
Technical success (successful introduction and deployment of the device in the absence of surgical conversion or mortality) plus freedom from the following: abdominal aneurysm rupture, conversion, Type I or III endoleak, graft limb occlusion and abdominal aneurysm size increase > 5 mm.
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 15 Jan 2021.
- Derived from this study: PubMed 39892792Lindsay TF, Harlock J, Herman C, Chen J, Power A, Saunders AT. A Canadian postmarket study of the Zenith Alpha Abdominal Endovascular Graft. J Vasc Surg. 2025 May;81(5):1058-1066.e1. doi: 10.1016/j.jvs.2025.01.196. Epub 2025 Jan 30.
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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.
Thomas Forbes, MD principal investigator
Toronto General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic and Aorto-iliac Aneurysm, run by Cook Research Incorporated at 5 sites in Canada.
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 3 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
Device Success (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061825, which also lists 1 linked publication.
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 15 Jan 2021.