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Zenith® p-Branch® OTS Multicenter Study

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
p-Branch®
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Aortic Aneurysm, Abdominal focused on measuring Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida
  • Methodist Hospital of Indiana
  • Community Heart and Vascular Hospital
  • University of Massachusetts Medical School
  • Mayo Clinic
  • Barnes-Jewish Hospital
  • Mercy Hospital
  • Hospital of the University of Pennsylvania
  • University of Texas Southwestern Medical Center at Dallas
  • The Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

p-Branch®

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 19, 2012
Last Updated
December 18, 2020
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01740700
Brief Title
Zenith® p-Branch® OTS Multicenter Study
Official Title
Zenith® p-Branch® Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal
Keywords
Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
p-Branch®
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
p-Branch®
Other Intervention Name(s)
Endovascular graft, Endovascular stent, Stent-graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical success
Description
Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.
Time Frame
Within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Farber, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Methodist Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Community Heart and Vascular Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33706000
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.
Results Reference
derived
PubMed Identifier
31255472
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.
Results Reference
derived
PubMed Identifier
28216359
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.
Results Reference
derived

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Zenith® p-Branch® OTS Multicenter Study

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