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

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:

Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients. Optimal patient selection, based on pathology and anatomy, is being defined. Technically successful implantation requires adequate assessment of pathology and anatomy, and development and execution of novel and delicate procedures that resolve the pathology while minimizing morbidity and mortality.

Study Overview

• Status: Completed
• Conditions: Aneurysm, Dissecting; Aortic Aneurysm, Thoracic
• Intervention / Treatment: Device: Endovascular Stent-graft repair of descending 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 TAG 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 TAG Endoprosthesis are located with in previous surgical grafts.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm - Placement of TAG device; A TAG device will be used to repair the pathology in the thoracic aorta	Device: Endovascular Stent-graft repair of descending thoracic aorta; A TAG device will be used to repair the pathology in the thoracic aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Technically Successful Implant	The percentage of participants with technically successful implantation as assessed by the investigator is reported.	Day 0 to Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants Experiencing at Least One Endoleak Following Procedure	Endoleak is persistent blood flow in the aneurysm sac.	Up to 60 months following procedure
Overall Survival	Overall survival is reported as the count of participants alive 60 months following implant procedure.	60 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Daniel Yung-Ho Sze, Stanford University

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 18, 2008
• First Submitted That Met QC Criteria: September 19, 2008
• First Posted (Estimate): September 22, 2008

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases
• Other Study ID Numbers: SU-09112008-1299; 13335 (SQL 73498) (Other Identifier: Stanford University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data is made available upon request to colleagues conducting similar studies throughout the US.