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.
Study Type
OBSERVATIONAL
Enrollment
30
Alfred Health
Melbourne, Australia
NOT_YET_RECRUITINGSir Charles Gairdner Hospital
Perth, Australia
NOT_YET_RECRUITINGRoyal North Shore Hospital
Saint Leonards, Australia
Mortality
Rate of all-cause mortality
Time frame: 30 days
Mortality
Rate of all-cause mortality
Time frame: 3-6 months, 12 months
Rupture
Rate of patients with aneurysm rupture
Time frame: through study completion, an average of 12 months
Major adverse events
Rate of patients with major adverse events
Time frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Number of interventions
Rate of interventions in peri-operative periods
Time frame: 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
Time frame: through study completion, an average of 12 months
Reinterventions
Rate of reinterventions
Time frame: 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)
Time frame: 12 months
Intercomponent separation
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Gold Coast University Hospital
Southport, Australia
NOT_YET_RECRUITINGAuckland City Hospital
Auckland, New Zealand
RECRUITINGWaikato Hospital Hamilton
Hamilton, New Zealand
RECRUITINGSiriraj Hospital
Bangkok, Thailand
RECRUITINGPrince of Songkla University - Songklanagarind Hospital
Songkhla, Thailand
RECRUITINGRate of patients with intercomponent separation at the proximal or distal end of the E-nside stent graft \> 10 mm
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Stent graft infection
Rate of patients with stent graft infection
Time frame: through study completion, an average of 12 months
Primary and secondary technical success
Rate of patients with primary/secondary technical success
Time frame: 24 hours
Primary and secondary clinical success
Rate of patients with primary/secondary clinical success
Time frame: 12 months
Stable, decreasing or increasing aneurysm size
Rate of patients with stable, decreasing or increasing aneurysm size
Time frame: 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
Time frame: through study completion, an average of 12 months