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| Name | Class |
|---|---|
| CMIC Co, Ltd. Japan | INDUSTRY |
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To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAMBE |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis | Device | The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Calculate the rate of achievement of technical success at the index procedure. The technical success is defined as follows. [Technical success] All of the following qualifying criteria are met:
| From the initial incision or puncture of the access vessel for the implantation procedure to the closure of the access vessel |
| Clinical Success | The achievement rate of clinical success will be calculated. The clinical success is defined as follows. [Clinical Success]
| 12 Months |
| Results related to abdominal branch vessels | Calculate the incidence of the following events related to abdominal branch vessels (celiac artery, superior mesenteric artery, left/ right renal arteries) or AC and stent grafts used in combination with AC for visceral branch vessels.
| 60 Months |
| Major Adverse Events (MAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katsuyuki Niwa | Contact | +819017754499 | kniwa@wlgore.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Jikei University Hospital | Recruiting | Minatoku | Japan | |||
| Nagoya University Hospital |
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| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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The incidence of any of following events is calculated.
All-cause mortality
Myocardial infarction resulting in death, cardiac arrest, or cardiopulmonary resuscitation
Respiratory failure requiring prolonged (> 24 hours) mechanical ventilation or reintubation
Renal function decline characterized by one or more of the following:
Bowel ischemia requiring surgical resection or not resolving with medical therapy
Permanent paraplegia
Major stroke (Any fatal or disabling stroke).
| 60 Months |
| Thirty-Day Mortality | Calculate thirty-day mortality. Thirty-day mortality is defined as follows. [Thirty-Day Mortality] Any death that occurs at the index procedure, within the index procedure hospital stay, or within the first 30 days post-index procedure. | 30 Days |
| Lesion-Related Mortality | Calculate lesion-related mortality. Lesion-related mortality is defined as follows. [Lesion-related mortality] Any death that occurs within the first 30 days, any death that results from lesion rupture, aorta-related adverse events (e.g., infection, occlusion, dissection, hematoma), or adverse events related to a secondary intervention. | 30 Days |
| Reintervention | Calculate the incidence of reintervention. Reintervention will be classified as "major" or "minor". Reintervention and its classifications are defined as follows. [Reintervention] Any procedure after the index procedure on the AC and stent grafts used in combination with AC. [Major Reintervention] Deployment the stent graft for proximal or distal side, removal of AC and stent grafts used in combination with AC, use of thrombectomy or thrombolysis, and surgical procedure. [Minor Reintervention] Treatment other than major reintervention that falls under any of the following categories
| 60 Months |
| Recruiting |
| Nagoya |
| Japan |
| Morinomiya Hospital | Recruiting | Osaka | Japan |
| Osaka International Medical & Science Center Osaka Police Hospital | Recruiting | Osaka | Japan |
| The University of Osaka Hospital | Recruiting | Suita | Japan |
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |