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SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)
Sponsor: B. Braun Melsungen AG
Summary
The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
Official title: PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1302
Start Date
2021-04-30
Completion Date
2027-03-31
Last Updated
2025-01-15
Healthy Volunteers
No
Interventions
SeQuent® SCB drug-coated balloon catheter
treatment of coronary artery disease with SeQuent® SCB of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts
Locations (1)
Universitätsklinikum Jena
Jena, Thuringia, Germany