To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
Primary Purpose
Aneurysm, Dissecting, Aortic Aneurysm, Thoracic
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Endovascular Stent-graft repair of descending thoracic aorta
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysm, Dissecting
Eligibility Criteria
Inclusion Criteria:
- Patients should be poor or high risk open surgical candidates.
- Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
- Anatomy meets TAG Endoprosthesis specification criteria.
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.
- Ability to comply with protocol requirements including follow-up.
- Signed Informed Consent
Exclusion Criteria:
- >4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
- Significant thrombus at the proximal or distal implantation sites.
- Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
- 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.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm - Placement of TAG device
Arm Description
A TAG device will be used to repair the pathology in the thoracic aorta
Outcomes
Primary Outcome Measures
Percentage of Participants With Technically Successful Implant
The percentage of participants with technically successful implantation as assessed by the investigator is reported.
Secondary Outcome Measures
Count of Participants Experiencing at Least One Endoleak Following Procedure
Endoleak is persistent blood flow in the aneurysm sac.
Overall Survival
Overall survival is reported as the count of participants alive 60 months following implant procedure.
Full Information
NCT ID
NCT00757003
First Posted
September 18, 2008
Last Updated
January 10, 2017
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT00757003
Brief Title
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm, Dissecting, Aortic Aneurysm, Thoracic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm - Placement of TAG device
Arm Type
Experimental
Arm Description
A TAG device will be used to repair the pathology in the thoracic aorta
Intervention Type
Device
Intervention Name(s)
Endovascular Stent-graft repair of descending thoracic aorta
Intervention Description
A TAG device will be used to repair the pathology in the thoracic aorta
Primary Outcome Measure Information:
Title
Percentage of Participants With Technically Successful Implant
Description
The percentage of participants with technically successful implantation as assessed by the investigator is reported.
Time Frame
Day 0 to Day 30
Secondary Outcome Measure Information:
Title
Count of Participants Experiencing at Least One Endoleak Following Procedure
Description
Endoleak is persistent blood flow in the aneurysm sac.
Time Frame
Up to 60 months following procedure
Title
Overall Survival
Description
Overall survival is reported as the count of participants alive 60 months following implant procedure.
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients should be poor or high risk open surgical candidates.
Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
Anatomy meets TAG Endoprosthesis specification criteria.
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.
Ability to comply with protocol requirements including follow-up.
Signed Informed Consent
Exclusion Criteria:
>4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
Significant thrombus at the proximal or distal implantation sites.
Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Yung-Ho Sze
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is made available upon request to colleagues conducting similar studies throughout the US.
Learn more about this trial
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
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