Status:
ACTIVE_NOT_RECRUITING
SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Coronary Artery Disease
Myocardial Ischaemia
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypa...
Eligibility Criteria
Inclusion
- All common significant coronary lesions
- Target lesion length \>34mm need to be covered with at least 2 devices
- Patients eligible for this study must be at least 18 years of age
- The patient must fulfil the standard recommendations for percutaneous coronary intervention (PCI), based on the last ESC recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment
Exclusion
- Intolerance to sirolimus
- Allergy to components of the coating
- Pregnancy and lactation
- Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
- Cardiogenic shock
- Risk of an intraluminal thrombus
- Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
- Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
- Severe allergy to contrast media
- Lesions which are untreatable with PCI or other interventional techniques
- Patients with an ejection fraction of \< 30 %
- Vascular reference diameter \< 2.00 mm
- Treatment of the left stem (first section of the left coronary artery)
- Indication for a bypass surgery
- Contraindication for whichever accompanying medication is necessary
Key Trial Info
Start Date :
April 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
1302 Patients enrolled
Trial Details
Trial ID
NCT04470934
Start Date
April 30 2021
End Date
March 31 2027
Last Update
January 15 2025
Active Locations (1)
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1
Universitätsklinikum Jena
Jena, Thuringia, Germany, 07747