NCT03033771

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
43mo left

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jan 2016Dec 2029

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Expected
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

6.9 years

First QC Date

January 19, 2017

Last Update Submit

February 6, 2024

Conditions

Aortic Dissection Type B

Outcome Measures

Primary Outcomes (4)

  • Re-establishment of the flow inside the true lumen

    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.

    30 days

  • Keeping all branches patent

    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.

    30 days

  • Re-establishment of the flow inside the true lumen

    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.

    12 months

  • Keeping all branches patent

    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.

    12 months

Secondary Outcomes (9)

  • Mortality at 30 days

    30 days

  • Number of Serious Adverse Events

    30 days, 12 months, 24 months and 36 months

  • Technical Success

    The technical success is evaluated/recorded post-procedure and presented in the 12 months report

  • Procedural/in-hospital evaluations (Anesthesia time)

    The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.

  • Procedural/in-hospital evaluations (Fluoroscopy time)

    The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.

  • +4 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Patients presenting with chronic type B aortic dissection will have the MFM implanted.

Device: Implantation with the Multilayer Flow Modulator (MFM)

Interventions

Implantation with the Multilayer Flow Modulator (MFM)DEVICE

Endovascular implantation with the MFM

Also known as: MFM, Multilayer Flow Modulator
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

City Clinic Burgas

Burgas, Bulgaria

Location

City Clinic Sofia

Sofia, Bulgaria

Location

Sanador Hospital

Bucharest, Romania

Location

European Hospital Polisano

Sibiu, 550172, Romania

Location

Study Officials

  • Victor Costache, MD PhD

    Sanador Hospital, Bucharest, Romania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 27, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2022

Study Completion (Estimated)

December 1, 2029

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

BU(2)RO(2)