A Study in Patients With Complicated Type B Aortic Dissection Treated With the E-nya Thoracic Ste… (NCT04378361) | Clinical Trial Compass
WithdrawnNot Applicable
A Study in Patients With Complicated Type B Aortic Dissection Treated With the E-nya Thoracic Stent Graft
Stopped: Expiry of CE mark.
Germany0Started 2020-05-25
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 85 years
* Complicated acute, subacute or chronic type B aortic dissection with evidence of at least one of the following:
* Malperfusion (visceral, renal, spinal cord and/or lower limb ischemia)
* Three of the following risk factors in acute or subacute dissections
* Young patient
* Primary entry tear \> 10 mm
* Early aortic expansion \> 5 mm within 6 months
* Total aortic diameter \> 40 mm
* False lumen diameter \> 20 mm
* Partially thrombosed false lumen
* Total diameter \> 50 mm in case of chronic dissections
* Patient is hemodynamically stable (stable blood pressure and heart rate, no shock)
* Planned proximal and distal landing zone of the E-nya Thoracic Stent Graft component(s) in the native aorta
* Landing zone of the proximal edge of the fabric distal to the left carotid artery
* Landing zone of the distal edge of the fabric proximal to the celiac trunk
* Proximal landing zone diameter between 20 and 44 mm
* Centerline distance from the distal edge of the left carotid artery to the start of the most proximal tear ≥ 20 mm
* Thoracic aortic lesion confirmed by thin sliced (≤ 1 mm) CTA with optional three-dimensional reconstruction obtained within 3 months prior to the implant procedure
* Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 12 months, and annually thereafter until 5 years follow-up
* Patient understands and …