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ACTIVE NOT RECRUITING
NCT04470934

SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)

Sponsor: B. Braun Melsungen AG

View on ClinicalTrials.gov

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

DEVICE

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