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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00757003
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 151
• Patients Per Site Per Month: 0.7

Study Details

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Oct 1, 2001
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Technically Successful Implant [Day 0 to Day 30]

   The percentage of participants with technically successful implantation as assessed by the investigator is reported.

Secondary Outcome Measures

1. Count of Participants Experiencing at Least One Endoleak Following Procedure [Up to 60 months following procedure]

   Endoleak is persistent blood flow in the aneurysm sac.

2. Overall Survival [60 months]

   Overall survival is reported as the count of participants alive 60 months following implant procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Ability to comply with protocol requirements including follow-up.

2. 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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Yung-Ho Sze, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT00757003
• Other Study ID Numbers: SU-09112008-1299; 13335 (SQL 73498)
• First Posted: Sep 22, 2008
• Last Update Posted: Mar 1, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Aneurysm, Dissecting; Aneurysm; Aortic Aneurysm; Aortic Diseases; Aortic Aneurysm, Thoracic

Study Results

Participant Flow

Recruitment Details	Enrollment October 2000 - November 2007. Patients presenting or transferred to Stanford University Medical Center with thoracic aortic pathology deemed prohibitively high risk for open surgical repair.

Arm/Group Title	Treatment Arm - Placement of TAG Device
Arm/Group Description	Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Period Title: Overall Study
STARTED	100
COMPLETED	51
NOT COMPLETED	49

Baseline Characteristics

Arm/Group Title	Treatment Arm - Placement of TAG Device
Arm/Group Description	Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Overall Participants	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.4 (17.4)
Gender (Count of Participants)
Female	31 31%
Male	69 69%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm - Placement of TAG Device
Arm/Group Description	Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Measure Participants	100
Number [percentage of participants]	99.0 99%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm - Placement of TAG Device
Arm/Group Description	A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta
Measure Participants	100
Count of Participants [Participants]	32 32%

3. Secondary Outcome

Title	Overall Survival
Description	Overall survival is reported as the count of participants alive 60 months following implant procedure.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

9 lost to followup, 4 withdrew, 2 explanted, 1 never implanted, all excluded

Arm/Group Title	Treatment Arm - Placement of TAG Device
Arm/Group Description	Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Measure Participants	84
Count of Participants [Participants]	51 51%

Adverse Events

Arm/Group Title	Treatment Arm - Placement of TAG Device
Arm/Group Description	A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta
All Cause Mortality
	Treatment Arm - Placement of TAG Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment Arm - Placement of TAG Device
	Affected / at Risk (%)	# Events
Total	43/100 (43%)
Cardiac disorders
cardiac arrhythmia	21/100 (21%)	21
angina	6/100 (6%)	6
Gastrointestinal disorders
bowel ischemia	3/100 (3%)	3
Nervous system disorders
change in mental status	11/100 (11%)	11
cerebrovascular accident	8/100 (8%)	8
paraplegia/paraparesis	1/100 (1%)	1
Renal and urinary disorders
renal failure	9/100 (9%)	9
renal insufficiency	7/100 (7%)	7
urinary tract infection	4/100 (4%)	4
Respiratory, thoracic and mediastinal disorders
Atelectasis/Pneumonia	28/100 (28%)	28
respiratory failure	13/100 (13%)	13
pulmonary embolism	12/100 (12%)	12
Skin and subcutaneous tissue disorders
lymphocele	4/100 (4%)	4
Surgical and medical procedures
procedural hemorrhage	12/100 (12%)	12
type I endoleak	13/100 (13%)	13
type II endoleak	7/100 (7%)	7
access failure	1/100 (1%)	1
Vascular disorders
thrombosis	3/100 (3%)	3
Other (Not Including Serious) Adverse Events
	Treatment Arm - Placement of TAG Device
	Affected / at Risk (%)	# Events
Total	16/100 (16%)
Vascular disorders
aortic diameter enlargement	16/100 (16%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.