Aorto-iliac AneurysmsNCT02571985
PRESERVE-Zenith® Iliac Branch System Clinical Extended Study
A study testing Zenith® Branch Endovascular Graft-Iliac Bifurcation System in people with Aorto-iliac Aneurysms and Iliac Aneurysms, run by Cook Group Incorporated at 19 sites in United States.
Trial summary
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorto-iliac Aneurysms, Iliac Aneurysms
- What is being tested?
- Zenith® Branch Endovascular Graft-Iliac Bifurcation System
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 19 sitesUnited States
- Study dates
- May 2012to Oct 2017
- Phase
- Expanded access
- 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
- An aortioiliac or iliac aneurysm
- An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery
Who cannot join
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Unsuitable arterial anatomy
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Emory University
Atlanta, Georgia, 30322
Christine E. Lynn Heart and Vascular Institute
Boca Raton, Florida, 33431
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22908
University of Florida
Gainesville, Florida, 32610
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, 53215
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical Center
New York, New York, 10065
VA Palo Alto HCS
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
Washington University School of Medicine
St Louis, Missouri, 63110
Mercy Hospital East Communities
St Louis, Missouri, 63141
Stanford University Medical School
Stanford, California, 94305
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation With the ConnectSX™
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms
- Conditions
- Aorto-iliac Aneurysms, Iliac Aneurysms
- Being tested
- Zenith® Branch Endovascular Graft-Iliac Bifurcation System
- Keywords
- Zenith aortoiliac aneurysm, iliac aneurysm, branch, connections, endovascular graft, graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases
- Medical subject headings
- Iliac Aneurysm, Aneurysm, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith® Branch Endovascular Graft-Iliac Bifurcation SystemDevice
Also called Endovascular repair for aortoiliac or iliac aneurysm
Zenith® Branch Endovascular Graft-Iliac Bifurcation (Branch Graft) with the ConnectSX™
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorto-iliac AneurysmsStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- W. Anthony Lee, MD FACS, Principal investigator, Christine E. Lynn Heart and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571985
- Sponsor's protocol ID
- 05-625 CA-P1
- Status last verified
- Mar 2017
- First submitted
- 28 Sep 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation With the ConnectSX™
- ClinicalTrials.gov ID
- NCT02571985
- Acronym / sponsor ID
- 05-625 CA-P1
- Conditions
- Aorto-iliac Aneurysms, Iliac Aneurysms
- Keywords
- Zenith aortoiliac aneurysm, iliac aneurysm, branch, connections, endovascular graft, graft-iliac bifurcation, Aneurysm, Vascular Diseases
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 8 Oct 2015 (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 PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An aortioiliac or iliac aneurysm
- An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Unsuitable arterial anatomy
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® Branch Endovascular Graft-Iliac Bifurcation SystemAlso: Endovascular repair for aortoiliac or iliac aneurysmZenith® Branch Endovascular Graft-Iliac Bifurcation (Branch Graft) with the ConnectSX™ | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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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.
W. Anthony Lee, MD FACS principal investigator
Christine E. Lynn Heart and Vascular Institute
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith® Branch Endovascular Graft-Iliac Bifurcation System in people with Aorto-iliac Aneurysms and Iliac Aneurysms, run by Cook Group Incorporated at 19 sites in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
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.
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 7 Mar 2017.