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ACTIVE NOT RECRUITING
NCT03033771
NA

Dragon Study Europe

Sponsor: Cardiatis

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Safety and Performance of the Multilayer Flow Modulator (MFM) for the Treatment of Chronic Type B Aortic Dissection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2016-01

Completion Date

2029-12

Last Updated

2024-02-07

Healthy Volunteers

No

Interventions

DEVICE

Implantation with the Multilayer Flow Modulator (MFM)

Endovascular implantation with the MFM

Locations (4)

City Clinic Burgas

Burgas, Bulgaria

City Clinic Sofia

Sofia, Bulgaria

Sanador Hospital

Bucharest, Romania

European Hospital Polisano

Sibiu, Romania