Abdominal Aortic AneurysmNCT01540643
Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
An observational study of Abdominal Aortic Aneurysm and Aorto-iliac Aneurysm, run by Cook Group Incorporated at 31 sites in 2 countries.
Trial summary
The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® 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?
- Iliac Leg Graft
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Mar 2012to Mar 2016
- 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 an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft
Who may be able to join
- Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg Graft.
Who cannot join
- Patients for whom this device would not normally be considered standard of care.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States27 sites
Albany Medical Center Hospital
Albany, New York, 12208
University Hospital
Augusta, Georgia, 30901
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
Bend Memorial Clinic
Bend, Oregon, 97701
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18045
St. Vincent's Heart and Vascular Center
Billings, Montana, 59101
Charleston Area Medical Center
Charleston, West Virginia, 25304
Missouri Heart Center
Columbia, Missouri, 65201
Mount Carmel East
Columbus, Ohio, 43213
Providence Regional Medical Center Everett
Everett, Washington, 98201
University of Florida
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Hospital
Hartford, Connecticut, 06102
Westchester Medical Center
Hawthorne, New York, 10532
Houston VA
Houston, Texas, 77030
Valley Vascular Consultants
Huntsville, Alabama, 35801
Physican's Regional Medical Center
Knoxville, Tennessee, 37909
University of Miami Hospital
Miami, Florida, 33136
Mount Sinai Medical Center
Miami Beach, Florida, 33140-2948
Froedert Hospital
Milwaukee, Wisconsin, 53226
Morristown Medical Center
Morristown, New Jersey, 07960
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Mount Sinai Hospital
New York, New York, 10029
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
University of Utah Hospital
Salt Lake City, Utah, 84132
Mercy Hospital Springfield
Springfield, Missouri, 65804
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 25157
Canada4 sites
Hamilton General Hospital
Hamilton, Ontario, L8L2X2
London Health Sciences Centre
London, Ontario, N6A 5W9
Ottawa Hospital Civic Campus
Ottawa, Ontario, K1Y 4E9
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.
- Conditions
- Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm
- Being tested
- Iliac Leg Graft
- Keywords
- abdominal aortic aneurysm, iliac leg graft
- 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.
Iliac Leg GraftDevice
Zenith® Spiral-Z® AAA Iliac Leg Graft
| Study group | Role | What they receive |
|---|---|---|
| Abdominal aortic aneurysm | Not described Receives: Device: Iliac Leg Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2016
- Study completionMar 2016
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 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lindsay, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540643
- Sponsor's protocol ID
- 11-015
- Status last verified
- Jan 2017
- First submitted
- 23 Feb 2012
- Last updated
- 20 Jan 2017
- Results posted
- No
Publications
Lindsay T, Jazaeri O, Sherman SM, Saunders AT, Forbes TL; Spiral-Z Registry Investigators. Final results from a postmarket registry of an iliac leg graft with a continuous, spiral nitinol stent. J Vasc Surg. 2020 Aug;72(2):576-583.e1. doi: 10.1016/j.jvs.2019.10.078. Epub 2020 Jan 19.
PubMed 31964568
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
- ClinicalTrials.gov ID
- NCT01540643
- Acronym / sponsor ID
- 11-015
- Conditions
- Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm
- Keywords
- abdominal aortic aneurysm, iliac leg graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Feb 2012 (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 registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal aortic aneurysm | – | Device: Iliac Leg Graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft
Key inclusion criteria (1 listed)
- Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg 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 |
|---|---|---|
| Iliac Leg GraftZenith® Spiral-Z® AAA Iliac Leg Graft | Device | Abdominal aortic aneurysm |
Primary outcome
Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft.
Time frame: 12 months
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 20 Jan 2017.
- Derived from this study: PubMed 31964568Lindsay T, Jazaeri O, Sherman SM, Saunders AT, Forbes TL; Spiral-Z Registry Investigators. Final results from a postmarket registry of an iliac leg graft with a continuous, spiral nitinol stent. J Vasc Surg. 2020 Aug;72(2):576-583.e1. doi: 10.1016/j.jvs.2019.10.078. Epub 2020 Jan 19.
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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 Lindsay principal investigator
Toronto General Hospital
31 sites in 2 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 31 sites in 2 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: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, 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?
Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft. (time frame: 12 months). 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 NCT01540643, 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 20 Jan 2017.