TAMBE: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
Study Details
Study Description
Brief Summary
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAMBE Device Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled. |
Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL [Absence of procedural safety events through 30 days post procedure]
Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Secondary Outcome Measures
- Technical Success, Including Individual Components of Technical Success [Ongoing throughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment]
Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure
- Device Integrity, Including Individual Components of Device Integrity [Ongoing throughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment]
Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components
- Patency (Primary, Assisted Primary, and Secondary) [Ongoing throughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment]
Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass.
- Absence of Type I and Type III Endoleaks at One Month Follow-up [One Month followup]
Absence of Type I and Type III endoleaks
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aortic aneurysm involving the visceral vessels requiring treatment
-
Adequate access for TAMBE Device components
-
Appropriate aortic anatomy to receive the TAMBE Device
-
Age ≥ 18 years at the time of informed consent signature
-
Male or infertile female
-
The patient is considered high risk for open repair as deemed by the treating physician
-
Capable of complying with protocol requirements, including follow-up
-
An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply
Exclusion Criteria:
-
Prior aortic surgery
-
Ruptured or leaking aortic aneurysm
-
Aneurysmal dilatation due to chronic aortic dissection
-
Infected aorta
-
Mycotic aneurysm
-
Life expectancy <2 years
-
Myocardial infarction or stroke within 6 weeks of treatment
-
Systemic infection which may increase risk of endovascular graft infection
-
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
-
Participation in another drug or medical device study within 1 year of study enrollment
-
History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
-
Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
-
Known sensitivities or allergies to the device materials
-
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
-
Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
-
Renal Insufficiency Note: Additional Exclusion Criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 2 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 3 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 4 | The Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 5 | University of North Carolina Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 6 | UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- W.L.Gore & Associates
Investigators
- Principal Investigator: Michel Makaroun, M.D., University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAA 13-02
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TAMBE Device |
|---|---|
| Arm/Group Description | Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
| Period Title: Overall Study | |
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | TAMBE Device |
|---|---|
| Arm/Group Description | Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
| Overall Participants | 10 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
70.2
(7.13)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1
10%
|
| Male |
9
90%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
7
70%
|
| Unknown or Not Reported |
3
30%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
10
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Height (Centimeters (cm)) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Centimeters (cm)] |
174.1
(9.72)
|
| Weight (Kilograms (kg)) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Kilograms (kg)] |
86.4
(20.6)
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
28.2
(5.07)
|
Outcome Measures
| Title | Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL |
|---|---|
| Description | Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL |
| Time Frame | Absence of procedural safety events through 30 days post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | TAMBE Device |
|---|---|
| Arm/Group Description | Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
| Measure Participants | 10 |
| Count of Participants [Participants] |
9
90%
|
| Title | Technical Success, Including Individual Components of Technical Success |
|---|---|
| Description | Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure |
| Time Frame | Ongoing throughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Device Integrity, Including Individual Components of Device Integrity |
|---|---|
| Description | Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components |
| Time Frame | Ongoing throughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Patency (Primary, Assisted Primary, and Secondary) |
|---|---|
| Description | Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass. |
| Time Frame | Ongoing throughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Absence of Type I and Type III Endoleaks at One Month Follow-up |
|---|---|
| Description | Absence of Type I and Type III endoleaks |
| Time Frame | One Month followup |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | 1 Year | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | TAMBE Device | |
| Arm/Group Description | Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) | |
All Cause Mortality |
||
| TAMBE Device | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/10 (10%) | |
Serious Adverse Events |
||
| TAMBE Device | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/10 (50%) | |
| Cardiac disorders | ||
| Cardiac failure congestive | 1/10 (10%) | 1 |
| Acute myocardial infarction | 1/10 (10%) | 1 |
| Gastrointestinal disorders | ||
| Diarrhoea | 1/10 (10%) | 1 |
| Illeus | 1/10 (10%) | 1 |
| General disorders | ||
| Vascular stent stenosis | 1/10 (10%) | 1 |
| Vascular stent occlusion | 1/10 (10%) | 1 |
| Hepatobiliary disorders | ||
| Cholecystitis acute | 1/10 (10%) | 1 |
| Infections and infestations | ||
| Pyelonephritis | 1/10 (10%) | 1 |
| Nervous system disorders | ||
| Spinal claudication | 1/10 (10%) | 1 |
| Renal and urinary disorders | ||
| Acute kidney injury | 1/10 (10%) | 1 |
| Renal artery occlusion | 1/10 (10%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnoea | 1/10 (10%) | 1 |
| Vascular disorders | ||
| Artery dissection | 1/10 (10%) | 1 |
| Arterial stenosis | 1/10 (10%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| TAMBE Device | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/10 (100%) | |
| Cardiac disorders | ||
| Acute myocardial infarction | 1/10 (10%) | 1 |
| Ventricular dyssynchrony | 1/10 (10%) | 1 |
| Sinus bradycardia | 1/10 (10%) | 1 |
| Gastrointestinal disorders | ||
| Colitis ischaemic | 1/10 (10%) | 1 |
| Constipation | 1/10 (10%) | 1 |
| Ileus paralytic | 1/10 (10%) | 1 |
| General disorders | ||
| Pyrexia | 1/10 (10%) | 1 |
| Stent-graft endoleak | 2/10 (20%) | 3 |
| Infections and infestations | ||
| Pneumonia | 1/10 (10%) | 1 |
| Septic Shock | 1/10 (10%) | 1 |
| Urinary tract infection | 1/10 (10%) | 1 |
| Injury, poisoning and procedural complications | ||
| Facial bones fracture | 1/10 (10%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 3/10 (30%) | 3 |
| Musculoskeletal pain | 1/10 (10%) | 1 |
| Pain in extremity | 2/10 (20%) | 2 |
| Nervous system disorders | ||
| Hypersomnia | 1/10 (10%) | 1 |
| Cerebrospinal fluid leakage | 1/10 (10%) | 1 |
| Hypoaesthesia | 3/10 (30%) | 3 |
| Seizure | 1/10 (10%) | 1 |
| Renal and urinary disorders | ||
| Urinary retention | 1/10 (10%) | 1 |
| Acute kidney injury | 2/10 (20%) | 2 |
| Renal infarct | 1/10 (10%) | 1 |
| Haematuria | 1/10 (10%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic obstructive pulmonary disease | 1/10 (10%) | 1 |
| Vascular disorders | ||
| Peripheral artery thrombosis | 1/10 (10%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Institution and Investigator agree not to submit any Publication until Study Completion and multi-center Publication has been published. If the multi-center Publication has not been submitted within 12 months of Study Completion, Institution and investigator may proceed with submission of the Publication; subject to the following: Investigator will provide all Publications to Sponsor for review that is more than 60 days but may extend an additional 120 days.
Results Point of Contact
| Name/Title | Rimma Zakharyan |
|---|---|
| Organization | W. L. Gore & Associates |
| Phone | 928 310 6961 |
| rzakhary@wlgore.com |
- AAA 13-02