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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cook
MED Institute, Incorporated
William Cook Australia
Information provided by (Responsible Party):
Cook ( William Cook Europe )
ClinicalTrials.gov Identifier:
NCT00526487
First received: September 5, 2007
Last updated: February 5, 2014
Last verified: February 2014
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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: 60
Study Start Date: December 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia
St. Vincent's Hospital Melbourne
Melbourne, Australia, VIC 3065
Czech Republic
St. Anne's Universtiy Hospital Brno
Brno, Czech Republic, 656 91
France
CHRU de Lille
Lille, Cedex, France, 59037
Germany
Hannover Medical School
Hannover, Germany, 30625
Heart Center Leipzig / Park Hospital
Leipzig, Germany, 04289
Clinic of Internal Medicine, University Hospital Rostock
Rostock, Germany, 18057
Italy
Hospital San Raffaele
Milan, Italy, 20129
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
William Cook Europe
Cook
MED Institute, Incorporated
William Cook Australia
Investigators
Principal Investigator: Joseph Lombardi, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Cook ( William Cook Europe )
ClinicalTrials.gov Identifier: NCT00526487     History of Changes
Other Study ID Numbers: 07-004, 370010, TXD
Study First Received: September 5, 2007
Last Updated: February 5, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Czech Republic: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Cook:
Thoracic Dissection
Dissection
Endovascular

ClinicalTrials.gov processed this record on November 27, 2014