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 range18 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 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
…
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