NCT01652235

Brief Summary

The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

15.2 years

First QC Date

July 17, 2012

Results QC Date

August 20, 2024

Last Update Submit

September 10, 2024

Conditions

Aortic Aneurysm, Abdominal

Keywords

Abdominal aortic aneurysmEndovascularFenestrationJuxtarenalOff-the-shelfPararenal

Outcome Measures

Primary Outcomes (3)

  • Technical Success:

    Successful access of the aneurysm site and deployment of the Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-Branch™ in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography

    Immediately post graft deployment

  • Procedural Success

    Technical Success, with all of the following at post-procedure (within 30 days): * No type I or type III endoleaks; * No procedure related serious adverse events or major complications; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.

    Within 30 days post graft deployment

  • Treatment Success

    Procedural Success, with all of the following at 12 months: * No type I or type III endoleaks; * No serious adverse events or major complications; * No aneurysm enlargement greater than 0.5 cm; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.

    12 months

Study Arms (1)

Endovascular

EXPERIMENTAL

Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft

Device: Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft

Interventions

Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular GraftDEVICE

Instead of making a large incision in the chest, 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 stent, Stent-graft
Endovascular

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Abdominal aortic aneurysm \> 5.0 cm or 2 times the normal aortic diameter
  • Abdominal aortic aneurysm with history of growth \> 0.5 cm in 6 months
  • Penetrating juxtarenal aortic ulcer \> 10 mm in depth and 20 mm in diameter

You may not qualify if:

  • Age \< 18 years
  • Life expectancy \< 2 years
  • Pregnant or breast feeding
  • Inability or refusal to give informed consent
  • Unwilling or unable to comply with the follow-up schedule
  • Additional medical restrictions as specified in the Clinical Investigation Plan
  • Additional anatomical restrictions as specified in the Clinical Investigation Plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai-West

New York, New York, 10025, United States

Location

New York Presbyterian Hospital System

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Results Point of Contact

Title
Alan Saunders, MS, RAC; Manager, Biostatistics
Organization
Cook Research Incorporated
Alan.Saunders@CookMedical.com
765-463-7537

Study Officials

  • James F. McKinsey, MD

    Mount Sinai-West

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 30, 2012

Study Start

July 1, 2008

Primary Completion

September 26, 2023

Study Completion

September 26, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-09

Locations

US(2)