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The INNER-B post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a thoracoabdominal aneurysm when treated by the E-nside TAAA Multibranch Stent Graft System.
The secondary objective is to evaluate the safety and clinical performance of the device.
In this study patients will be observed, who receive an E-nside TAAA Multibranch Stent Graft System for the endovascular treatment 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.
The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular repair | Device | Endovascular repair of thoracoabdominal aneurysm using stent grafts. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of all-cause mortality | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of all-cause mortality in peri-operative periods (all related interventions) | 24 hours |
| Mortality | Rate of all-cause mortality |
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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 inclusion / exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Dittmar Böckler, Prof. Dr. | University Hospital Heidelberg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 3-6, 12, 24, 36, 60 months |
| Rupture | Rate of patients with aneurysm rupture | 30-day, 3-6, 12, 24, 36, 60 months |
| Major Adverse Events (MAE) | Rate of patients with major adverse events (aneurysm related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke, visceral ischemia (bowel ischemia with surgery or submission to ICU or bowel necrosis with surgery or submission to ICU), new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, new permanent paraplegia, new permanent paraparesis, lower limb ischemia (increase in Rutherford classification) (product-related, procedure-related, aneurysm-related) | prior to discharge, 30 days, 3-6, 12, 24, 36, 60 months |
| Number of intervention(s) | Rate of interventions in peri-operative periods (all related interventions until index procedure) | perioperative |
| Delivery time | 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 | perioperative |
| Reintervention | Rate of reintervention(s) | 30 days, 3-6, 12, 24, 36, 60 months |
| Endoleak Type Ia | Rate of patients with type Ia endoleak | 12, 24, 36, 60 months |
| Endoleak Type Ib | Rate of patients with type Ib endoleak | 12, 24, 36, 60 months |
| Endoleak Type Ic | Rate of patients with type Ic endoleak | 12, 24, 36, 60 months |
| Endoleak Type II | Rate of patients with type II endoleak | 12, 24, 36, 60 months |
| Endoleak Type III | Rate of patients with type III endoleak | 12, 24, 36, 60 months |
| Endoleak Type IV | Rate of patients with type IV endoleak | 12, 24, 36, 60 months |
| Endoleak of unknown origin | Rate of patients with endoleak of unknown origin | 12, 24, 36, 60 months |
| Proximal intercomponent separation | Rate of patients with intercomponent separation at the proximal end of the E-nside stent graft > 10 mm | prior to discharge/30 days, 12, 24, 36, 60 months |
| Distal intercomponent separation | Rate of patients with intercomponent separation at the distal end of the E-nside stent graft > 10 mm | prior to discharge/30 days, 12, 24, 36, 60 months |
| Integrity | Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break) | prior to discharge/30 days, 12, 24, 36, 60 months |
| Kinking | Rate of patients with E-nside stent graft or bridging stent graft kinking | prior to discharge/30 days, 12, 24, 36, 60 months |
| Primary patency | Rate of primary patency of bridging stents | prior to discharge/30 days, 12, 24, 36, 60 months |
| Primary patency of bridging stent of the celiac trunk | Rate of primary patency of the bridging stent of the celiac trunk | prior to discharge/30 days, 12, 24, 36, 60 months |
| Primary patency of bridging stent of the superior mesenteric artery | Rate of primary patency of the bridging stent of the superior mesenteric artery | prior to discharge/30 days, 12, 24, 36, 60 months |
| Primary patency of bridging stent of the right renal artery | Rate of primary patency of the bridging stent of the right renal artery | prior to discharge/30 days, 12, 24, 36, 60 months |
| Primary patency of bridging stent of the left renal artery | Rate of primary patency of the bridging stent of the left renal artery | prior to discharge/30 days, 12, 24, 36, 60 months |
| Secondary patency | Rate of secondary patency of bridging stents | prior to discharge/30 days, 12, 24, 36, 60 months |
| Secondary patency of the bridging stent of the celiac trunk | Rate of secondary patency of the bridging stent of the celiac trunk | prior to discharge/30 days, 12, 24, 36, 60 months |
| Secondary patency of the bridging stent of the superior mesenteric artery | Rate of secondary patency of the bridging stent of the superior mesenteric artery | prior to discharge/30 days, 12, 24, 36, 60 months |
| Secondary patency of the bridging stent of the right renal artery | Rate of secondary patency of the bridging stent of the right renal artery | prior to discharge/30 days, 12, 24, 36, 60 months |
| Secondary patency of the bridging stent of the left renal artery | Rate of secondary patency of the bridging stent of the left renal artery | prior to discharge/30 days, 12, 24, 36, 60 months |
| Infection | Rate of patients with stent graft infection | 30-day, 12, 24, 36, 60 months |
| Primary technical success | Rate of patients with primary technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated within 24 h after the index procedure. Successful introduction and deployment of the E-nside TAAA Multibranch Stent Graft in the absence of: Surgical conversion Mortality Reintervention Unplanned branch vessel occlusion (post-operative occlusion) Including: Secure proximal and distal fixation Patent treated branch vessels | 24 hours |
| Technical success | Rate of patients with technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure. | 24 hours |
| Primary clinical success | Rate of patients with primary clinical success. Primary clinical success is reported on an intent-to-treat basis and is reached if the following criteria are fulfilled at the time of follow-up starting at 12 months follow-up: Successful deployment of the endovascular devices at the intended location in the absence of: Death as result of aneurysm-related treatment Conversion to open repair Reintervention after index procedure Occlusion of treated branch vessels Type I or III endoleak Increasing aneurysm size Aneurysm rupture | 12, 24, 36, 60 months |
| Clinical success | Rate of patients with clinical success. Clinical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure. | 12, 24, 36, 60 months |
| Stable aneurysm size | Rate of patients with stable aneurysm size | 12, 24, 36, 60 months |
| Decreasing (< 5 mm) aneurysm size | Rate of patients with decreasing aneurysm size | 12, 24, 36, 60 months |
| Increasing (> 5 mm) aneurysm size | Rate of patients with increasing aneurysm size | 12, 24, 36, 60 months |
| Stent graft removal | Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft | 24 hours, prior to discharge/30 days, 12, 24, 36, 60 months |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |