TX2® Low Profile TAA Endovascular Graft (TX2® LP)

This study is currently recruiting participants.

Verified March 2013 by Cook

Sponsor:

Information provided by (Responsible Party):

Cook

ClinicalTrials.gov Identifier:

NCT01151020

First received: June 22, 2010

Last updated: March 16, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 22, 2010

Last Updated Date

March 16, 2013

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Freedom from major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01151020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Device Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Device Success is defined as: graft patency with freedom from aneurysm growth, rupture, conversion to open surgical procedure and endoleak.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

TX2® Low Profile TAA Endovascular Graft

Official Title ^ICMJE

Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Brief Summary

The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Aortic Aneurysm
Penetrating Ulcer
Vascular Disease

Intervention ^ICMJE

Device: Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)

Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair

Other Name: TEVAR

Study Arm (s)

Experimental: Arm 1

Intervention: Device: Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

110

Estimated Completion Date

April 2018

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Descending thoracic aneurysm with diameter ≥ 5.0 cm
Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

Less than 18 years of age
Life expectancy less than 2 years
Pregnant or breastfeeding or planning on becoming pregnant within 60 months
Unwilling to comply with the follow-up schedule
Inability or refusal to give informed consent
Less than 30 days beyond primary endpoint for other investigative drug or device study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jennifer Gilmore

765-463-7537

jgilmore@medinst.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01151020

Other Study ID Numbers ^ICMJE

10-001

Has Data Monitoring Committee

Not Provided

Responsible Party

Cook

Study Sponsor ^ICMJE

Cook

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Karl Illig, MD

Tampa General Hospital

Information Provided By

Cook

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top