The CONFORM-TAD post-market clinical follow-up study is undertakento evaluate the prevention of death related to the treatment of a complicated acute, subacute or chronic type B aortic dissection with the E-nya Thoracic Stent Graft System. The secondary objective is to evaluate safety and clinical performance of the device.
In this study, patients who receive an E-nya Thoracic Stent Graft for the treatment of a complicated acute, subacute or chronic type B aortic dissection will be observed. The E-nya Thoracic Stent Graft will be implanted in accordance with the instructions for use of the E-nya Thoracic Stent Graft System and at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine standard of care for patients he/she had decided to treat with the E-nya Thoracic Stent Graft System. Informed consent of the patients will be obtained to allow the use of their clinical records for the purpose of this observational study before data are being collected. The period of data collection for each patient will be approximately 60 months from the intervention. 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.
Study Type
OBSERVATIONAL
Endovascular repair of complicated acute, subacute or chronic type B aortic dissection with double lumen
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Mortality
Rate of all-cause mortality
Time frame: 30-day
Mortality
Rate of all-cause mortality
Time frame: 24 hours
Mortality
Rate of all-cause mortality
Time frame: 12, 24, 36, 60 months
Dissection related mortality
Rate of dissection related mortality
Time frame: 30-day, 12, 24, 36, 60 months
Primary technical success
Primary technical success related to the E-nya Thoracic Stent Graft System combines the following criteria: * It is related to periprocedural events that occur from the initiation of the procedure and extend through the first 24-hours postoperative period * Defined on an intent-to-treat basis * Successful access to the arterial system using a remote site (ie, the femoral, external iliac, common iliac, abdominal aorta, or brachiocephalic arteries with or without use of a temporary or permanent prosthetic conduit to access these arteries) * Successful deployment of the endoluminal graft at the intended location * Coverage of the primary entry tear * Absence of reintervention, surgical conversion to open repair or death ≤24 h * Patent endoluminal graft
Time frame: 24 hours
Technical success
Technical success is achieved in case all above mentioned criteria are fulfilled however, a reintervention was performed.
Time frame: 24 hours
Primary clinical success
Primary clinical success related to the E-nya Thoracic Stent Graft combines the following criteria: * Clinical success should be reported on an intent-to-treat basis * Initially required successful deployment of the E-nya Thoracic Stent Graft at the intended location without any * Death as a result of the pathology that was treated * Conversion to open repair * Reintervention * E-nya Thoracic Stent Graft infection * E-nya Thoracic Stent Graft infolding * Causing a new thoracic aortic pathology as a result of the intervention (e.g. pseudoaneurysm, dissection, intramural hematoma)
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Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Clinical success
Clinical success is achieved in case all above mentioned criteria are fulfilled however, a reintervention was performed.
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Major Adverse Events (MAE)
• Rate of patients with major adverse event(s) (death, aneurysm rupture , conversion to open surgical repair, retrograde type A dissection, stent graft induced new entry tear requiring intervention, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke, new permanent paraplegia, new permanent paraparesis, new chronic renal insufficiency/renal failure requiring dialysis, bowel resection, \> 72 hours artificial respiratory assistance, device induced trauma requiring intervention) product-related, procedure-related, dissection-related)
Time frame: 30-day, 12, 24, 36, 60 months
Conversion to open surgical repair
Rate of patients with conversion to open surgical repair
Time frame: 24 hours, 30-day, 12, 24, 36, 60 months
Size of true lumen
Rate of patients with increasing (\>5 mm) or stable true lumen in the stented region
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Size of false lumen
Rate of patients with stable or decreasing (\<5 mm) false lumen in the stented region
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Status of false lumen
Rate of patients with obliterated, completely thrombosed, partially thrombosed, or patent false lumen in the stented region (top, middle, 2 cm proximal to distal end), between the bottom of the stent and the celiac trunk, and between the celiac trunk and the aortic bifurcation
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Primary entry tear
Rate of patients with covered primary entry tear
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Secondary intervention(s)
Rate of patients with secondary intervention(s)
Time frame: 30-day, 12, 24, 36, and 60 months
Reintervention(s)
Rate of patients with reintervention(s)
Time frame: 30-day, 12, 24, 36, and 60 months
Cerebrovascular event
Rate of patients with new cerebrovascular event/stroke (excluding transient ischemic attack)
Time frame: 30-day, 12, 24, 36, and 60 months
Permanent paraplegia
Rate of patients with a new permanent paraplegia
Time frame: 30-day, 12, 24, 36, and 60 months
Permanent paraparesis
Rate of patients with a new permanent paraparesis
Time frame: 30-day, 12, 24, 36, and 60 months
Migration
Rate of E-nya stent graft migration * Rate of patients with proximal E-nya Thoracic Stent Graft migration \>5 mm * Rate of patients with distal E-nya Thoracic Stent Graft migration \>5 mm
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Dislodgement
Rate of patients with E-nya Stent Graft dislodgement (full component separation)
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Integrity
Rate of patients with failure of E-nya Stent Graft integrity (stent fracture, fabric erosion)
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Infolding
Rate of patients with infolding of an E-nya Stent Graft
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months