Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAMBE Device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis | Device | Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 | Absence of procedural safety events through 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success, Including Individual Components of Technical Success | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michel Makaroun, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30612825 | Derived | Oderich GS, Farber MA, Silveira PG, Tadros R, Marin M, Fillinger M, Makaroun M, Hemmer J, Madden M. Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Aug;70(2):358-368.e6. doi: 10.1016/j.jvs.2018.10.103. Epub 2019 Jan 3. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2017 | Jun 7, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 12-month |
| Device Integrity, Including Individual Components of Device Integrity | 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 | 12-month |
| Patency (Primary, Assisted Primary, and Secondary) | 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. | 12-month |
| Absence of Type I and Type III Endoleaks at One Month Follow-up | Absence of Type I and Type III endoleaks | One Month followup |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| The Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | Centimeters (cm) |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | Kilograms (kg) |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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 | Posted | Count of Participants | Participants | Absence of procedural safety events through 30 days post procedure |
|
|
| |||||||||||||||||||||||||||
| Secondary | Technical Success, Including Individual Components of Technical Success | 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 | Posted | Count of Participants | Participants | 12-month |
|
| ||||||||||||||||||||||||||||
| Secondary | Device Integrity, Including Individual Components of Device Integrity | 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 | Posted | Count of Participants | Participants | 12-month |
|
| ||||||||||||||||||||||||||||
| Secondary | Patency (Primary, Assisted Primary, and Secondary) | 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. | Posted | Count of Participants | Participants | 12-month |
|
| ||||||||||||||||||||||||||||
| Secondary | Absence of Type I and Type III Endoleaks at One Month Follow-up | Absence of Type I and Type III endoleaks | Includes only subjects with evaluable imaging within the one month window | Posted | Count of Participants | Participants | One Month followup |
|
|
5 Years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) | 5 | 10 | 10 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Illeus | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Vascular stent occlusion | General disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Vascular stent stenosis | General disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Cirrhosis alcoholic | Hepatobiliary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Cystilis | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Squamos cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V24.1 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Spinal claudication | Nervous system disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Artery dissection | Vascular disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA V24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Ventricular dyssynchrony | Cardiac disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Stent-graft endoleak | General disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Vascular stent occlusion | General disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V24.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA V24.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA V24.1 | Systematic Assessment |
| |
| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Renal atrophy | Renal and urinary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA V24.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA V24.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rimma Zakharyan | W. L. Gore & Associates | 928 310 6961 | rzakhary@wlgore.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2015 | Jun 7, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|