Dragon Study Europe (NCT03033771) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dragon Study Europe
Bulgaria, Romania27 participantsStarted 2016-01
Plain-language summary
Dragon Study Europe is an international, multicenter, prospective, non-randomized study. It is designed to evaluate safety and performance of the MFM for the treatment of chronic type B aortic dissection. About 35 patients in up to 11 countries will be enrolled and screened per the protocol-required inclusion, exclusion criteria, in order to obtain 30 completed patients. For early demonstration of safety and performance, an interim analysis report will be performed after all patients included will complete their 6-month follow-up.
The study purpose is to determine the safety and performance of the MFM for the endovascular treatment of chronic type B aortic dissection. It should be noted that the MFM has CE mark approval for aortic and peripheral artery aneurysms treatment.
Who can participate
Age range
18 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 over 18
* Life expectancy \> 12 months
* Informed consent understood, signed and patient agrees to all follow-up visits
* Chronic type B aortic dissection must be presenting with at least one of the following factors:
* Uncontrollable hypertension
* Persistent back/chest pain despite medical treatment
* Expansion of aortic diameter (false lumen and total diameter)
* With risk of progression, i.e. partial thrombosis of the false lumen
* Healthy proximal and distal landing zone
* Adequate arterial anatomy to perform EVAR by MFM
* Healthy branches and collaterals (no stenosis or previously treated by angioplasty)
* The patient must be available for the appropriate follow-up visits for the study duration
Exclusion Criteria:
* Stage 4 or 5 Renal Insufficiency as per K/DOQI clinical practice guidelines for chronic kidney disease (GFR \< 29ml/min/1.73m²)
* Dissection or aneurysm rupture, impending or contained rupture
* Aortic root aneurysm
* Pleural effusion untreated at the procedure time
* Prior all surgical procedure within 30 days unless procedure is in preparation for device implantation or planned within 30 days post stent deployment
* Myocardial infarction or cerebral vascular accident within 6 weeks of treatment
* Presence/suspicion of connective tissue disorders, for example, Marfan or Ehlers-Danlos etc.
* Contraindications to the anticoagulant or/ and antiplatelet medications
* Thrombocytopenia
* Allergic reaction to a contrast agent
…
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.
What they're measuring
1
Re-establishment of the flow inside the true lumen
Timeframe: 30 days
2
Keeping all branches patent
Timeframe: 30 days
3
Re-establishment of the flow inside the true lumen