A Study in Patients With Complicated Type B Aortic Dissection Treated With the E-nya Thoracic Stent Graft
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Vascular Diseases
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
In this study, patients who receive an E-nya Thoracic Stent Graft for the treatment of a complicated acute, subacute or chronic type B aortic dissection will be observed. The E-nya Thoracic Stent Graft will be implanted in accordance with the instructions for use of the E-nya Thoracic Stent Graft Sy...
In this study, patients who receive an E-nya Thoracic Stent Graft for the treatment of a complicated acute, subacute or chronic type B aortic dissection will be observed. The E-nya Thoracic Stent Graft will be implanted in accordance with the instructions for use of the E-nya Thoracic Stent Graft System and at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine standard of care for patients he/she had decided to treat with the E-nya Thoracic Stent Graft System. Informed consent of the patients will be obtained to allow the use of their clinical records for the purpose of this observational study before data are being collected. The period of data collection for each patient will be approximately 60 months from the intervention. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.
Tracking Information
- NCT #
- NCT04378361
- Collaborators
- MedPass International
- Investigators
- Study Director: Jan Brunkwall, Prof. Brumed Study Chair: Jost P. Schäfer, Prof. University Hospital Schleswig-Holstein (UKSH) Kiel