Zenith® p-Branch® OTS Multicenter Study

NCT01740700 | Completed FDA Device

• 1 other identifier: 12-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

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).

Conditions

Aortic Aneurysm, Abdominal

Keywords

Abdominal aortic aneurysm; Endovascular; Fenestration; Juxtarenal; Off-the-shelf; Pararenal

Outcome Measures

Primary Outcomes (1)

• Technical success

  Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.

  Within 30 days

Study Arms (1)

p-Branch®

EXPERIMENTAL

Device: p-Branch®

Interventions

p-Branch® DEVICE

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.

Also known as: Endovascular graft, Endovascular stent, Stent-graft

p-Branch®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (10)

University of Florida

Gainesville, Florida, 32610, United States

Location

Methodist Hospital of Indiana

Indianapolis, Indiana, 46202, United States

Location

Community Heart and Vascular Hospital

Indianapolis, Indiana, 46250, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Mercy Hospital

St Louis, Missouri, 63141, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 33706000 DERIVED

• 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.

  PMID: 31255472 DERIVED

• 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.

  PMID: 28216359 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Mark A Farber, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 22, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

US (10)