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

Coronary Artery Disease Clinical Trial

— SCORE  

Official title:

PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470934
• Other study ID #: AAG-O-H-1913
• Status: Recruiting
• Start date: April 30, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: B. Braun Melsungen AG
• Contact: Sylvia Otto, MD
• Phone: +49 3641 932 45 60
• Email: Sylvia.Otto[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1302
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischaemia
• Myocardial Ischemia

Intervention

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

Country	Name	City	State
Germany	Universitätsklinikum Jena	Jena	Thüringen

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	at 12 months
Secondary	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).	at 24 months
Secondary	ischemia driven target lesion revascularization (TLR)		at 12 months
Secondary	ischemia driven target lesion revascularization (TLR)		at 24 months
Secondary	all-cause death, cardiac death		at 12 months
Secondary	all-cause death, cardiac death		at 24 months
Secondary	all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)		at 12 months
Secondary	all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)		at 24 months
Secondary	major adverse coronary event (MACE)	major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization	at 12 months
Secondary	major adverse coronary event (MACE)	major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization	at 24 months
Secondary	Dual Antiplatelet Therapy (DAPT) compliance		at 4 weeks
Secondary	Dual Antiplatelet Therapy (DAPT) compliance		at 3 months
Secondary	Probable or definite stent-thrombosis of In-stent treated lesions		accumulated at 12 months
Secondary	Probable or definite stent-thrombosis of In-stent treated lesions		accumulated at 24 months
Secondary	Procedural success	final diameter stenosis < 30 % without flow-limiting dissections	immediately after procedure
Secondary	Bleeding complications according to the Bleeding Academic Research Consortium (BARC)		accumulated at 3 months
Secondary	Bleeding complications according to the Bleeding Academic Research Consortium (BARC)		accumulated at 12 months
Secondary	Bleeding complications according to the Bleeding Academic Research Consortium (BARC)		accumulated at 24 months