Aorto-iliac AneurysmsNCT01208415
PRESERVE-Zenith® Iliac Branch System Clinical Study
A study testing Endovascular repair for aortoiliac or iliac aneurysms. 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 study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms. 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?
- Endovascular repair for aortoiliac or iliac aneurysms.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 19 sitesUnited States
- Study dates
- Jan 2011to 10 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 aortoiliac or iliac aneurysm of appropriate size
- Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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
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 Center
Stanford, California, 94305
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.
- Conditions
- Aorto-iliac Aneurysms, Iliac Aneurysms
- Being tested
- Endovascular repair for aortoiliac or iliac aneurysms.
- 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.
Endovascular repair for aortoiliac or iliac aneurysms.Device
Also called Endovascular repair for aortoiliac or iliac aneurysm.
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.
| Study group | Role | What they receive |
|---|---|---|
| Device Implant | Experimental | Not described Receives: Device: Endovascular repair for aortoiliac or iliac aneurysms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients That Are Free From Patency-related Intervention
Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
- NCT01208415
- Sponsor's protocol ID
- 05-625-P1
- Status last verified
- Sep 2017
- First submitted
- 23 Sep 2010
- Last updated
- 4 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESERVE-Zenith® Iliac Branch System Clinical Study
- ClinicalTrials.gov ID
- NCT01208415
- Acronym / sponsor ID
- 05-625-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
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 24 Sep 2010 (estimated)
- Results
- Posted 16 Aug 2017
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 study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Implant | Experimental | Device: Endovascular repair for aortoiliac or iliac aneurysms. |
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 aortoiliac or iliac aneurysm of appropriate size
- Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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 |
|---|---|---|
| Endovascular repair for aortoiliac or iliac aneurysms.Also: Endovascular repair for aortoiliac or iliac aneurysm.Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft. | Device | Device Implant |
Primary outcome
Patients That Are Free From Patency-related Intervention
Time frame: 6 Months
Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Endovascular repair for aortoiliac or iliac aneurysms. 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: finished, as of the sponsor's last update on 4 Apr 2018. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patients That Are Free From Patency-related Intervention (time frame: 6 Months). 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 4 Apr 2018.