Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection - Full Text View

Sponsors and Collaborators:	William Cook Europe Cook MED Institute, Incorporated William Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00526487

Purpose

The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

Condition	Intervention
Aortic Dissection Involving the Descending Thoracic Aorta	Device: Zenith® Dissection Endovascular System Device: Endovascular Repair

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta

Further study details as provided by Cook:

Primary Outcome Measures:

The primary endpoint is survival at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Endovascular Repair	Device: Zenith® Dissection Endovascular System The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta. Device: Endovascular Repair Endovascular Repair

Arms

Assigned Interventions

1

Endovascular Repair

Device: Zenith® Dissection Endovascular System

The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

Device: Endovascular Repair

Endovascular Repair

Detailed Description:

The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Branch vessel obstruction/compromise
Peri-aortic effusion/hematoma
Resistant hypertension
Persistent pain/symptoms
Transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm)

Exclusion Criteria:

Age less than 18 years
Frank rupture
Diagnosed or suspected congenital degenerative connective tissue disease
Systemic infection
Untreatable reaction to contrast
Surgical/endovascular AAA repair within 30 days
Previous placement of thoracic endovascular graft
Prior repair of descending thoracic aorta
Interventional/open procedures within 30 days
Onset of symptoms > 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526487

Locations

Australia
St. Vincent's Hospital Melbourne	Recruiting
Melbourne, Australia, VIC 3065
Contact: Peter Mossop, MD +61 (3) 9288-4310 mossoppj@svhm.org.au
Principal Investigator: Peter Mossop, MD
Royal Brisbane & Women's Hospital	Recruiting
Herston, Brisbane, Australia, QLD 4029
Contact: Jason Jenkins, MD +61 (7) 3636-3301 jason_jenkins@health.qld.gov.au
Principal Investigator: Jason Jenkins, MD
Czech Republic
St. Anne's Universtiy Hospital Brno	Recruiting
Brno, Czech Republic, 656 91
Contact: Jiri Ondrasek, MD +420-543-211-528 jiri.ondrasek@cktch.cz
Principal Investigator: Jiri Ondrasek, MD
France, Cedex
CHRU de Lille	Not yet recruiting
Lille, Cedex, France, 59037
Contact: Stephan Haulon, MD +0320 445 811 s-haulon@chru-lille.fr
Principal Investigator: Stephan Haulon, MD
Germany
Clinic of Internal Medicine, University Rostock	Recruiting
Rostock, Germany, 18057
Contact: Christoph Nienaber, MD +49-38-1497-9904 christoph.neinaber@med.uni-rostock.de
Principal Investigator: Christoph Nienaber, MD
Klinikum Harlaching, Stadtisches Klinikum Munchen GmbH	Not yet recruiting
Munchen, Germany, 81377
Contact: Reinhard Kopp, MD +49-89-7095-3510 r.kopp@khmh.de
Principal Investigator: Reinhard Kopp, MD
Hannover Medical School	Recruiting
Hannover, Germany, 30625
Contact: Omke Teebken, MD +49-51-1532-4895 teebken.omke@MH-Hannover.de
Principal Investigator: Omke Teebken, MD
Heart Center Leipzig / Park Hospital	Recruiting
Leipzig, Germany, 04289
Contact: Dierk Scheinert, MD +49-0341-8650-1405 dierk.scheinert@gmx.de
Principal Investigator: Dierk Scheinert, MD
Italy
Hospital San Raffaele	Recruiting
Milan, Italy, 20129
Contact: Roberto Chiesa, MD +39-02-2643-7146 chiesa.robert@hsr.it
Principal Investigator: Roberto Chiesa, MD
IRCCS Policlinico San Matteo	Recruiting
Pavia, Italy, 27100
Contact: Prof. Attillio Odero +39-03-8250-2790 aodero@smattero.pv.it
Principal Investigator: Attillio Odero, Prof.

Sponsors and Collaborators

William Cook Europe

Cook

MED Institute, Incorporated

William Cook

Investigators

Principal Investigator:

Joseph Lombardi, MD

Thomas Jefferson University Hospital

More Information

No publications provided

Responsible Party:	Cook ( April Lavender, Vice President for Regulatory Affairs )
Study ID Numbers:	07-004, 370010
Study First Received:	September 5, 2007
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00526487 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Cook:

Thoracic Dissection
Dissection
Endovascular

ClinicalTrials.gov processed this record on May 07, 2009