Clinical trial NCT01740700: Zenith® p-Branch® OTS Multicenter Study
Official title: Zenith® p-Branch® Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: Abdominal aortic aneurysm
Endovascular
Fenestration
Juxtarenal
Off-the-shelf
Pararenal
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Technical success
timeFrame: Within 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Indianapolis
country: United States
facility: Methodist Hospital of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Community Heart and Vascular Hospital
state: Indiana
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: University of North Carolina
name: Mark A Farber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Farber 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.
citation: Timaran 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.