Aneurysm, Dissecting, Aortic Aneurysm, Thoracic
Conditions
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.
Interventions
DEVICEEndovascular Stent-graft repair of descending thoracic aorta
A TAG device will be used to repair the pathology in the thoracic aorta
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Overall Survival | 60 months | Overall survival is reported as the count of participants alive 60 months following implant procedure. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm - Placement of TAG Device 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. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 33 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Not implanted | 1 |
| Overall Study | Surgically explanted | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Treatment Arm - Placement of TAG Device |
|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 17.4 |
| Gender Female | 31 Participants |
| Gender Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 100 |
| serious Total, serious adverse events | 43 / 100 |
Outcome results
Primary
Percentage of Participants With Technically Successful Implant
The percentage of participants with technically successful implantation as assessed by the investigator is reported.
Time frame: Day 0 to Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm - Placement of TAG Device | Percentage of Participants With Technically Successful Implant | 99.0 percentage of participants |
Secondary
Count of Participants Experiencing at Least One Endoleak Following Procedure
Endoleak is persistent blood flow in the aneurysm sac.
Time frame: Up to 60 months following procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm - Placement of TAG Device | Count of Participants Experiencing at Least One Endoleak Following Procedure | 32 Participants |
Secondary
Overall Survival
Overall survival is reported as the count of participants alive 60 months following implant procedure.
Time frame: 60 months
Population: 9 lost to followup, 4 withdrew, 2 explanted, 1 never implanted, all excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm - Placement of TAG Device | Overall Survival | 51 Participants |