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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2024 |
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Main ID: |
NCT03033771 |
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Date of registration:
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19/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dragon Study Europe
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Scientific title:
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Evaluation of the Safety and Performance of the Multilayer Flow Modulator (MFM) for the Treatment of Chronic Type B Aortic Dissection |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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27 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03033771 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bulgaria
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Romania
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Turkey
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Contacts
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Name:
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Victor Costache, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanador Hospital, Bucharest, Romania |
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Key inclusion & exclusion criteria
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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
- Patient with undergoing or planned chemotherapy
- History of bleeding disorder (coagulopathy) or thrombophilia
- Patient with atrial fibrillation who are under anticoagulation therapy
- Presence/suspicion of infection (for example: mycotic aorta)
- The use of the MFM with stent-grafts or previously implanted stent-grafts
- Pregnant or breastfeeding woman
- Patients included in another clinical study
- Severe left ventricular dysfunction
- Significant arrhythmias
- Severe valvular disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aortic Dissection Type B
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Intervention(s)
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Device: Implantation with the Multilayer Flow Modulator (MFM)
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Primary Outcome(s)
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Re-establishment of the flow inside the true lumen
[Time Frame: 12 months]
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Re-establishment of the flow inside the true lumen
[Time Frame: 30 days]
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Keeping all branches patent
[Time Frame: 30 days]
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Keeping all branches patent
[Time Frame: 12 months]
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Secondary Outcome(s)
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Mortality at 30 days
[Time Frame: 30 days]
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Number of Serious Adverse Events
[Time Frame: 30 days, 12 months, 24 months and 36 months]
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Procedural/in-hospital evaluations (Fluoroscopy time)
[Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]
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Technical Success
[Time Frame: The technical success is evaluated/recorded post-procedure and presented in the 12 months report]
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Procedural/in-hospital evaluations (Estimated Blood loss)
[Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]
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Procedural/in-hospital evaluations (Contrast Volume)
[Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report]
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Procedural/in-hospital evaluations (time to hospital discharge)
[Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]
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Procedural/in-hospital evaluations (Anesthesia time)
[Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]
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Procedural/in-hospital evaluations (procedure time)
[Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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