Clinical Trial Details

NCT ID: NCT01663064
Date Last Changed: January 20, 2015

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Endovascular treatment (Zenith® p-Branch™ endovascular graft) to evaluate Aortic Aneurysm or Abdominal Aortic Aneurysm

Research Study Title

Zenith® p-Branch™: Single-Center Study

Purpose

The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Cook
Duration
36 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Pararenal or juxtarenal AAA > 5.0 cm in diameter

  • Pararenal or juxtarenal AAA with history of growth > 0.5 cm/year

Exclusion Criteria:

  • Age < 18 years

  • Life expectancy < 2 years

  • Pregnant or breast feeding

  • 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

  • Additional medical restrictions as specified in the Clinical Investigation Plan

  • Additional anatomical restrictions as specified in the Clinical Investigation Plan

Site Locations (1)

Country State City Zip Facility and Contact
Sweden Malmo SE-205 02 Skane University Hospital
Timothy A. Resch, MD, PhD
+46 40331000
timothyresch@gmail.com

Contact

Trine Toelboell, DVM, PhD
+45 56868971
E-mail:

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