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Dragon Study Europe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033771
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Cardiatis

Brief 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.


Condition or disease Intervention/treatment Phase
Aortic Dissection Type B Device: Implantation with the Multilayer Flow Modulator (MFM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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. The main interim analysis, aiming at the early demonstration of safety and performance, will be performed after all patients included will complete their 6-month follow-up. A preliminary interim analysis will be performed on the first patients enrolled (15 completed patients) and with their 6-months follow-up available.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Performance of the Multilayer Flow Modulator (MFM) for the Treatment of Chronic Type B Aortic Dissection
Actual Study Start Date : January 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Treatment
Patients presenting with chronic type B aortic dissection will have the MFM implanted.
Device: Implantation with the Multilayer Flow Modulator (MFM)
Endovascular implantation with the MFM
Other Name: MFM, Multilayer Flow Modulator




Primary Outcome Measures :
  1. Re-establishment of the flow inside the true lumen [ Time Frame: 30 days ]
    the re-establishment of the flow inside the true lumen will be evaluated using medical imagery. Data will be compaired to pre-op imaregy, and will be presented as a percentage of patient with true lumen repressurization compared to baseline.

  2. Keeping all branches patent [ Time Frame: 30 days ]
    the patency of branches emerging from the treated portion of the aorta will be evaluated and compared to pre-op data. Data will be presented as a percentage of branches patent per total number of branches involved in the diseased and treated portion of the aorta.

  3. Re-establishment of the flow inside the true lumen [ Time Frame: 12 months ]
    the re-establishment of the flow inside the true lumen will be evaluated using medical imagery. Data will be compared to pre-op imaregy, and will be presented as a percentage of patient with true lumen repressurization compared to baseline.

  4. Keeping all branches patent [ Time Frame: 12 months ]
    the re-establishment of the flow inside the true lumen will be evaluated using medical imagery. Data will be compaired to pre-op imaregy, and will be presented as a percentage of patient with true lumen repressurization compared to baseline.


Secondary Outcome Measures :
  1. Mortality at 30 days [ Time Frame: 30 days ]
    Percentage of patients deceased at 30 days

  2. Number of Serious Adverse Events [ Time Frame: 30 days, 12 months, 24 months and 36 months ]
  3. Technical Success [ Time Frame: The technical success is evaluated/recorded post-procedure and presented in the 12 months report ]
    Successful delivery and deployment of the MFM

  4. 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. ]
    descriptive statistics on Anesthesia time (min)

  5. 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. ]
    Descriptive Statistics on fluoroscopy time (min)procedure time; time to hospital discharge

  6. 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 ]
    Descriptive Statistics on contrast volume (ml)

  7. 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. ]
    Descriptive Statistics on contrast Estimated Blood loss (ml)

  8. 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. ]
    Descriptive Statistics on procedure time (min)

  9. 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. ]
    Descriptive Statistics on time to hospital discharge (days).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033771


Contacts
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Contact: Ralf Kolvenbach, MD +49 (0)1722 62 4563 Ralf.Kolvenbach@vkkd-kliniken.de

Locations
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Bulgaria
City Clinic Burgas Recruiting
Burgas, Bulgaria
Contact: Dr. Mariana Konteva         
City Clinic Sofia Recruiting
Sofia, Bulgaria
Contact: Pr. Ivo Petrov         
Romania
European Hospital Polisano Active, not recruiting
Sibiu, Romania, 550172
Turkey
Cukurova University Medical Faculty Balcali Hospital Recruiting
Adana, Turkey
Contact: Dr. Ugur Gocen         
Bezm-i Alem Vakif universitesi Tip Fakültesi Hastanesi Recruiting
Istanbul, Turkey
Contact: Dr. Bekir Inan         
Kartal Kosuyolu Yuksek Ihtisas Research and Training Hospital Recruiting
Istanbul, Turkey
Contact: Dr. Mustafa Akbulut         
Sponsors and Collaborators
Cardiatis
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Responsible Party: Cardiatis
ClinicalTrials.gov Identifier: NCT03033771    
Other Study ID Numbers: 04-2015
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases