Aortic Aneurysm AbdominalNCT02396199
Zenith® p-Branch® Endovascular Graft Pivotal Study
A study testing Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents in people with Aortic Aneurysm Abdominal, run by Cook Research Incorporated at 27 sites in United States.
Trial summary
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm Abdominal
- What is being tested?
- Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 27 sitesUnited States
- Study dates
- Aug 2015to 28 Jan 2025
- 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
- Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
- Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
- Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation
Who cannot join
- Age <18 years
- Life expectancy <2 years
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Inability or refusal to give informed consent by the patient or a legally authorized representative
- Unwilling or unable to comply with the follow-up schedule
- Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
- Additional medical restrictions as specified in the Clinical Investigation Plan
- Additional anatomical restrictions as specified in the Clinical Investigation Plan
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Emory University Hospital
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama Birmingham Hosptial
Birmingham, Alabama, 35233
Boca Raton Community Hospita
Boca Raton, Florida, 33486
UT Southwestern
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 27710
Hartford Hospital
Hartford, Connecticut, 06102-8000
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
The Methodist Hospital - Smith Tower
Houston, Texas, 77030
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202
Baylor Scott and White Research Institute
Irving, Texas, 75061
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Minneapolis Heart Inst. Foundation
Minneapolis, Minnesota, 55407
New York University - Langone Medical Center
New York, New York, 10016
Mount Sinai Roosevelt
New York, New York, 10025
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Joseph's Hospital and Medical Center-Dignity Health
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Kaiser Permanente
San Francisco, California, 94115
Barnes Jewish Hospital Plaza
St Louis, Missouri, 63110
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Stanford University Medical School
Stanford, California, 94305
Tampa General Hospital
Tampa, Florida, 33601
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Zenith® p-Branch® Pivotal Study
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
- Conditions
- Aortic Aneurysm Abdominal
- Being tested
- Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
- Keywords
- Abdominal aortic aneurysm, Endovascular, Juxtarenal, Pararenal, Fenestrated
- 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.
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stentsDevice
Also called Endovascular graft, Endovascular stent, Stent-graft, Fenestrated graft
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular | Experimental | Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents Receives: Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success Proportion
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
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 posted24 Mar 2015 (estimated)
- Study startAug 2015
- Primary completion1 Apr 2021
- Study completion28 Jan 2025
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 Aortic Aneurysm AbdominalStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark A Farber, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396199
- Sponsor's protocol ID
- 14-09
- Status last verified
- Feb 2025
- First submitted
- 12 Mar 2015
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® p-Branch® Pivotal Study
- ClinicalTrials.gov ID
- NCT02396199
- Acronym / sponsor ID
- 14-09
- Conditions
- Aortic Aneurysm Abdominal
- Keywords
- Abdominal aortic aneurysm, Endovascular, Juxtarenal, Pararenal, Fenestrated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Posted 25 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular | Experimental | Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stentsEndovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
- Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
- Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation
Key exclusion criteria (8 listed)
- Age <18 years
- Life expectancy <2 years
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Inability or refusal to give informed consent by the patient or a legally authorized representative
- Unwilling or unable to comply with the follow-up schedule
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® p-Branch® in combination with the Atrium iCAST™ covered stentsAlso: Endovascular graft, Endovascular stent, Stent-graft, Fenestrated graftInstead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta. | Device | Endovascular |
Primary outcome
Treatment Success Proportion
Time frame: 12 months
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- 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.
Mark A Farber, MD principal investigator
University of North Carolina
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents in people with Aortic Aneurysm Abdominal, run by Cook Research Incorporated at 27 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 3 inclusion and 8 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 25 Oct 2022). 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?
Treatment Success Proportion (time frame: 12 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 19 Feb 2025.