Aortic Aneurysm, AbdominalNCT01740700
Zenith® p-Branch® OTS Multicenter Study
A study testing p-Branch® in people with Aortic Aneurysm, Abdominal, run by Cook Research Incorporated at 10 sites in United States.
Trial summary
The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA). 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?
- p-Branch®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2013to 22 Jun 2020
- Phase
- Interventional
- 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
- 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
University of Florida
Gainesville, Florida, 32610
The Methodist Hospital
Houston, Texas, 77030
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Mercy Hospital
St Louis, Missouri, 63141
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Zenith® p-Branch® Multicenter Study
The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- p-Branch®
- Keywords
- Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
- 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.
p-Branch®Device
Also called Endovascular graft, Endovascular stent, Stent-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 |
|---|---|---|
| p-Branch® | Experimental | Not described Receives: Device: p-Branch® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01740700
- Sponsor's protocol ID
- 12-002
- Status last verified
- Dec 2020
- First submitted
- 19 Oct 2012
- Last updated
- 21 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Attaran RR, Bhalla A, Mena-Hurtado CI, Ochoa Chaar CI. Correlation between great saphenous length of treatment zone and diameter with improvement in symptoms after ablation. J Vasc Surg Venous Lymphat Disord. 2021 Nov;9(6):1443-1450. doi: 10.1016/j.jvsv.2021.02.013. Epub 2021 Mar 9.
PubMed 33706000Farber MA, Oderich GS, Timaran C, Sanchez LA, Dawson Z; Zenith p-Branch Feasibility Study Investigators. Results from a prospective multicenter feasibility study of Zenith p-Branch stent graft. J Vasc Surg. 2019 Nov;70(5):1409-1418.e3. doi: 10.1016/j.jvs.2019.03.026. Epub 2019 Jun 27.
PubMed 31255472Timaran DE, Knowles M, Ali T, Timaran CH. Fenestrated endovascular aneurysm repair among octogenarians at high and standard risk for open repair. J Vasc Surg. 2017 Aug;66(2):354-359. doi: 10.1016/j.jvs.2016.11.064. Epub 2017 Feb 16.
PubMed 28216359
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith® p-Branch® Multicenter Study
- ClinicalTrials.gov ID
- NCT01740700
- Acronym / sponsor ID
- 12-002
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 4 Dec 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 the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| p-Branch® | Experimental | Device: p-Branch® |
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 |
|---|---|---|
| p-Branch®Also: Endovascular graft, Endovascular stent, Stent-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 | p-Branch® |
Primary outcome
Technical success
Time frame: Within 30 days
Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.
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 21 Dec 2020.
- Derived from this study: PubMed 33706000Attaran RR, Bhalla A, Mena-Hurtado CI, Ochoa Chaar CI. Correlation between great saphenous length of treatment zone and diameter with improvement in symptoms after ablation. J Vasc Surg Venous Lymphat Disord. 2021 Nov;9(6):1443-1450. doi: 10.1016/j.jvsv.2021.02.013. Epub 2021 Mar 9.
- Derived from this study: PubMed 31255472Farber MA, Oderich GS, Timaran C, Sanchez LA, Dawson Z; Zenith p-Branch Feasibility Study Investigators. Results from a prospective multicenter feasibility study of Zenith p-Branch stent graft. J Vasc Surg. 2019 Nov;70(5):1409-1418.e3. doi: 10.1016/j.jvs.2019.03.026. Epub 2019 Jun 27.
- Derived from this study: PubMed 28216359Timaran DE, Knowles M, Ali T, Timaran CH. Fenestrated endovascular aneurysm repair among octogenarians at high and standard risk for open repair. J Vasc Surg. 2017 Aug;66(2):354-359. doi: 10.1016/j.jvs.2016.11.064. Epub 2017 Feb 16.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing p-Branch® in people with Aortic Aneurysm, Abdominal, run by Cook Research Incorporated at 10 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
Technical success (time frame: Within 30 days). 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 NCT01740700, which also lists 3 linked publications.
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 21 Dec 2020.