Clinical trial NCT04470934: SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)
Official title: PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Myocardial Ischaemia
Keywords: Coronary Artery Disease
Myocardial Ischemia
drug-coated balloon catheter
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 1302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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).

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: at 12 months
Secondary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: at 24 months
measure: ischemia driven target lesion revascularization (TLR)
timeFrame: at 12 months
measure: ischemia driven target lesion revascularization (TLR)
timeFrame: at 24 months
measure: all-cause death, cardiac death
timeFrame: at 12 months
measure: all-cause death, cardiac death
timeFrame: at 24 months
measure: all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)
timeFrame: at 12 months
measure: all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)
timeFrame: at 24 months
measure: major adverse coronary event (MACE)
timeFrame: at 12 months
measure: major adverse coronary event (MACE)
timeFrame: at 24 months
measure: Dual Antiplatelet Therapy (DAPT) compliance
timeFrame: at 4 weeks
measure: Dual Antiplatelet Therapy (DAPT) compliance
timeFrame: at 3 months
measure: Probable or definite stent-thrombosis of In-stent treated lesions
timeFrame: accumulated at 12 months
measure: Probable or definite stent-thrombosis of In-stent treated lesions
timeFrame: accumulated at 24 months
measure: Procedural success
timeFrame: immediately after procedure
measure: Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
timeFrame: accumulated at 3 months
measure: Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
timeFrame: accumulated at 12 months
measure: Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
timeFrame: accumulated at 24 months
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
Study officials:
affiliation: Universitätsklinikum Jena - Klinik für Innere Medizin I
name: Sylvia Otto, MD
role: PRINCIPAL_INVESTIGATOR
References: