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

Aortic Aneurysm, Thoracic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757003
• Other study ID #: SU-09112008-1299
• Secondary ID: 13335 (SQL 73498
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2008
• Last updated: April 13, 2016
• Start date: October 2001
• Est. completion date: May 2014

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUSA:Stanford University IRB
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Diseases

Intervention

Device:
• Endovascular Stent-graft repair of descending thoracic aorta
A TAG device will be used to repair the aneurysm in the thoracic aorta

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical, Treatment and Clinical Success		1month, 6 month and 12 month respectively	No
Primary	Technical, Treatment and Clinical Success		1month, 6 month and 12 month respectively	Yes
Secondary	Procedural blood loss, length of hospital stay, return to activities of daily living		Through 12 months post procedure	No
Secondary	Outcome Measure: Procedural blood loss, length of hospital stay, return to activities of daily living		Through 12 months post procedure	Yes