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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.