An observational study in Coronary Artery Disease and Myocardial Ischaemia, sponsored by B. Braun Melsungen AG. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by B. Braun Melsungen AG · Observational
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).
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 bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical data) with 80% power. Primary and secondary outcome variables are international accepted parameters in stent-trials, which sufficiently describe the efficacy and safety of the investigated device and allow clinical conclusions. Additional attention will be paid to those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT).
The aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4 mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion is longer than 34 mm, more than one stent needs to be used.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 1,302 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →B. Braun Melsungen AG is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a single-armed, prospective, international, multi-center, post-market study in patients with coronary artery disease and indication for PCI either due to anginal symptoms and a relevant stenotic coronary lesion during angiography or due to documented ischemia by non-invasive or invasive functional testing.
All patients who undergo a target intervention with the SCB will be followed for 12 and 24 months after initial PCI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment of coronary artery disease with SeQuent® SCB of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts
Target Lesion Failure (TLF)
Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).
Time frame: at 12 months
Target Lesion Failure (TLF)
Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).
Time frame: at 24 months
ischemia driven target lesion revascularization (TLR)
Time frame: at 12 months
ischemia driven target lesion revascularization (TLR)
Time frame: at 24 months
all-cause death, cardiac death
Time frame: at 12 months
all-cause death, cardiac death
Time frame: at 24 months
all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)
Time frame: at 12 months
all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)
Time frame: at 24 months
major adverse coronary event (MACE)
major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization
Time frame: at 12 months
major adverse coronary event (MACE)
major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization
Time frame: at 24 months
Dual Antiplatelet Therapy (DAPT) compliance
Time frame: at 4 weeks
Dual Antiplatelet Therapy (DAPT) compliance
Time frame: at 3 months
Probable or definite stent-thrombosis of In-stent treated lesions
Time frame: accumulated at 12 months
Probable or definite stent-thrombosis of In-stent treated lesions
Time frame: accumulated at 24 months
Procedural success
final diameter stenosis \< 30 % without flow-limiting dissections
Time frame: immediately after procedure
Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
Time frame: accumulated at 3 months
Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
Time frame: accumulated at 12 months
Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
Time frame: accumulated at 24 months
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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