NCT04470934Active, not recruiting
SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)
PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1302 (estimated)
- First submitted
- 10 Jul 2020
- Start date
- 30 Apr 2021
- Primary completion date
- 3 Mar 2026
- Lead sponsor
- B. Braun Melsungen AG
- Diseases
- Coronary artery disease
- NCT number
- NCT04470934
What you commit to
- Study type: Observational
- Planned participants: 1302
- From 30 Apr 2021 to the primary completion date, 3 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for a bypass surgery
- Contraindication for whichever accompanying medication is necessary
Other illness
- Allergy to components of the coating
- Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
- Severe allergy to contrast media
Lab values
- 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
- Patients with an ejection fraction of \< 30 %
Other
- Intolerance to sirolimus
- Pregnancy and lactation
- Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
- Cardiogenic shock
- Risk of an intraluminal thrombus
- Lesions which are untreatable with PCI or other interventional techniques
- Vascular reference diameter \< 2.00 mm
- Treatment of the left stem (first section of the left coronary artery)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.