Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Conditions
Brief summary
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.
Interventions
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.
Sponsors
W.L.Gore & Associates
CMIC Co, Ltd. Japan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who were attempted to implant the AC * Thoracoabdominal aortic aneurysm * Pararenal abdominal aortic aneurysm
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | From the initial incision or puncture of the access vessel for the implantation procedure to the closure of the access vessel | 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: * Successful access to the access vessels * Successful delivery and deployment of AC and all stent grafts used in combination with AC to its intended location * Successful side branch delivery catheterization and placement of all stent grafts used in the side branch area to its intended location * Absence of type I or type III endoleaks at final completion image evaluation * Patency of AC and all stent grafts used in combination with AC at final completion image evaluation * Absence of open surgical repair conversion or mortality |
| Clinical Success | 12 Months | The achievement rate of clinical success will be calculated. The clinical success is defined as follows. \[Clinical Success\] * Achievement of technical success * Absence of the events listed below from the time of the index procedure to 12 months after the index procedure 1. Death from the index procedure 2. Death from reintervention 3. Death from aorta-related causes 4. Persistent type I or type III endoleaks 5. Lesion enlargement \>5 mm 6. Device migration \>10 mm 7. Failure due to device integrity issues 8. Lesion rupture 9. Conversion to open surgical repair 10. Permanent paraplegia 11. Disabling stroke 12. New-onset dialysis |
| Results related to abdominal branch vessels | 60 Months | 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. * Primary Patency * Primary Assisted Patency * Secondary Patency * Occlusion * Stenosis * Kink * Target vessel instability * Intraprocedural Complications |
| Major Adverse Events (MAEs) | 60 Months | 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: 1. \> 50% reduction in pre-treatment Estimated Glomerular Filtration Rate (eGFR) 2. New-onset dialysis * Bowel ischemia requiring surgical resection or not resolving with medical therapy * Permanent paraplegia * Major stroke (Any fatal or disabling stroke). |
| Thirty-Day Mortality | 30 Days | 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. |
| Lesion-Related Mortality | 30 Days | 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. |
| Reintervention | 60 Months | 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 * Endovascular procedures (percutaneous transluminal angioplasty, atherectomy, stenting) * Interventions to treat branch vessel stenosis * Interventions to treat type II endoleaks or branch-related endoleaks. |
Countries
Japan
Contacts
CONTACTKatsuyuki Niwa
Outcome results
None listed