To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00757003
First received: September 18, 2008
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety and Efficacy study

Official Title: A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Diseases for Non-Surgical Candidates under the Physician Sponsored IDE.

PURPOSE OF RESEARCH:

You are invited to participate in a research study for treatment of aneurysms of the descending thoracic aorta. The investigational device, called the TAG Thoracic Endoprosthesis (device) has been designed to simplify treatment of aneurysms of the descending thoracic aorta. The other pathologies treated can include pseudoaneurysms, acute and chronic dissections, penetrating ulcers, mycotic aneurysms, ruptures, fistulae, and transections.The device is made from a graft (an artificial vessel) which is surrounded on the outside by a metal mesh-like form. The device is in the shape of a tube. The device reinforces the weakened part of the aorta from the inside. Blood flows through the device to the arteries that go to your abdomen and legs. The device is folded tightly onto a catheter (a flexible, hollow tube) that is put into the aorta through an artery in your leg. Unless there is a problem, you would not need to have your chest opened.


Condition Intervention Phase
Aneurysm, Dissecting
Aortic Aneurysm, Thoracic
Device: Endovascular Stent-graft repair of descending thoracic aorta
Phase 3

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: A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Diseases for Non-Surgical Candidates Under the Physician Sponsored IDE.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Technical, Treatment and Clinical Success [ Time Frame: 1month, 6 month and 12 month respectively ] [ Designated as safety issue: No ]
  • Technical, Treatment and Clinical Success [ Time Frame: 1month, 6 month and 12 month respectively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Procedural blood loss, length of hospital stay, return to activities of daily living [ Time Frame: Through 12 months post procedure ] [ Designated as safety issue: No ]
  • Outcome Measure: Procedural blood loss, length of hospital stay, return to activities of daily living [ Time Frame: Through 12 months post procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2001
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm - Placement of TAG device
A TAG device will be placed in the Aorta to treat the AAA
Device: Endovascular Stent-graft repair of descending thoracic aorta
A TAG device will be used to repair the aneurysm in the thoracic aorta

Detailed Description:

STUDY DESCRIPTION:

There will be a maximum of 100 patients treated with the new device. You will be evaluated by your doctor to determine if you are able to participate in this research study. This evaluation will include reviewing your medical history, a physical examination, and special x-rays. These special x-rays are called CT scans and angiograms. Your doctor will explain what tests you will have done. A CT scan is a special x-ray that allows your doctor to see the size and shape of your aorta and your arteries. An angiogram uses a catheter (a hollow tube) that is placed into your arteries. Both tests use dye that can be seen on x-rays to see how the blood flows through your aorta and the surrounding arteries; for the CT scan it will be injected into a vein, and for the angiogram it is injected through the catheter into your arteries. These tests would be conducted whether or not you were participating in this research study. Your doctor will use this type of testing to determine if you are eligible to participate in this research study and as part of your follow-up care. Currently there are two aortic stent grafts manufactured by W.L. Gore & Associates that are approved by the FDA for experimental use. Your doctor will determine which device is more appropriate to treat your condition.

  Eligibility

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

Inclusion Criteria:

  1. Patients should be poor or high risk open surgical candidates.
  2. Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
  3. Anatomy meets Thoracic EXCLUDER Endoprosthesis specification criteria.
  4. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm

    • <60 angle in the aortic arch may require additional length of non-aneurysmal segment is the arch is included in the treatment segment.
  5. Ability to comply with protocol requirements including follow-up.
  6. Signed Informed Consent

Exclusion Criteria:

  1. >4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
  2. Significant thrombus at the proximal or distal implantation sites.
  3. Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
  4. Degenerative connective tissue disease, e.g. Marfan's or Ehler's danlos Syndrome, unless the proximal and distal implantation sites of the Thoracic EXCLUDER Endoprosthesis are located with in previous surgical grafts.

6. Female of child bearing age with positive pregnancy test.

  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: NCT00757003

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Daniel Yung-Ho Sze Stanford University
  More Information

No publications provided

Responsible Party: Daniel Yung-Ho Sze, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00757003     History of Changes
Other Study ID Numbers: SU-09112008-1299, 13335 (SQL 73498)
Study First Received: September 18, 2008
Last Updated: July 27, 2011
Health Authority: United States: Food and Drug Administration
USA:Stanford University IRB

Additional relevant MeSH terms:
Aneurysm
Aneurysm, Dissecting
Aortic Aneurysm
Aortic Diseases
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014