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The INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with thoracoabdominal aortic aneurysms.
In this study, patients will be observed who are planned to be treated an E-nside TAAA Multibranch Stent Graft System for endovascular repair of a degenerative, atherosclerotic thoracoabdominal aortic aneurysm. The E-nside TAAA Multibranch Stent Graft will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-nside TAAA Multibranch Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. Patient data will be documented in an eCRF at the following time points: Pre-operative planning, intervention(s), discharge(s) from hospital, 30 days, 3-6 and 12 months follow-up. The period of data collection will be approximately 12 months (depending on the time point of the 12 months FU visit) from the index procedure for each patient. A 100% source data verification will be performed regarding patient information and consent, criteria of patients to be documented, pre-operative planning, intervention(s), treatment results, adverse events, death, and reintervention. Complete DICOM image files of the CT scans will be sent to a CoreLab for independent second evaluation.
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of all-cause mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of all-cause mortality | 3-6 months, 12 months |
| Rupture | Rate of patients with aneurysm rupture | through study completion, an average of 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients with degenerative, atherosclerotic thoracoabdominal aortic aneurysm who are scheduled for implantation of an E-nside TAAA Multibranch Stent Graft at their physician's discretion and who are eligible in accordance with the criteria listed below.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Health | Melbourne | 3004 | Australia | |||
| Sir Charles Gairdner Hospital |
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| Major adverse events | Rate of patients with major adverse events | Prior to Discharge, 30 days, 3-6 months, 12 months |
| Number of interventions | Rate of interventions in peri-operative periods | Intra-Op |
| Time E-nside delivery system remained in access vessels | Rate of time intervals the E-nside delivery system remained in the access vessels in relation to the number of branches treated with pre-cannulation | through study completion, an average of 12 months |
| Reinterventions | Rate of reinterventions | 30 days, 3-6, 12 months |
| Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin | Rate of patients with type Ia, Ib, Ic endoleak (at 12 months follow-up) | 12 months |
| Intercomponent separation | Rate of patients with intercomponent separation at the proximal or distal end of the E-nside stent graft > 10 mm | Prior to Discharge, 30 days, 3-6 months, 12 months |
| Loss of device integrity | Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break) | Prior to Discharge, 30 days, 3-6 months, 12 months |
| Kinking of E-nside Stent Graft or bridging stents | Rate of patients with E-nside stent graft or bridging stent kinking | Prior to Discharge, 30 days, 3-6 months, 12 months |
| Primary and secondary patency (overall and separately for each type of branch) | Rate of primary/secondary patency of bridging stents Rate of primary/secondary patency of the bridging stent of the celiac trunk Rate of primary/secondary patency of the bridging stent of the superior mesenteric artery Rate of primary/secondary patency of the bridging stent of the right renal artery Rate of primary/secondary patency of the bridging stent of the left renal artery Rate of primary/secondary patency of branch vessels treated | Prior to Discharge, 30 days, 3-6 months, 12 months |
| Stent graft infection | Rate of patients with stent graft infection | through study completion, an average of 12 months |
| Primary and secondary technical success | Rate of patients with primary/secondary technical success | 24 hours |
| Primary and secondary clinical success | Rate of patients with primary/secondary clinical success | 12 months |
| Stable, decreasing or increasing aneurysm size | Rate of patients with stable, decreasing or increasing aneurysm size | 12 months |
| Removal or failure to implant the stent graft | Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft | through study completion, an average of 12 months |
| Perth |
| 6009 |
| Australia |
| Royal North Shore Hospital | Saint Leonards | 2065 | Australia |
| Gold Coast University Hospital | Southport | 4215 | Australia |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Waikato Hospital Hamilton | Hamilton | 3204 | New Zealand |
| Siriraj Hospital | Bangkok | Thailand |
| Prince of Songkla University - Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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