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

NCT ID: NCT04470934

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1302 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2027-03-31

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.

Conditions

Coronary Artery Disease; Myocardial Ischaemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia Otto, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Jena - Klinik für Innere Medizin I

Locations

Universitätsklinikum Jena

Jena, Thuringia, Germany

Countries

Germany

References

Otto S, Diaz VAJ, Weilenmann D, Cuculi F, Nuruddin AA, Leibundgut G, Alfonso F, Wan Ahmad WA, Pyxaras S, Rittger H, Steen P, Gaede L, Schulze C, Wohrle J, Rosenberg M, Waliszewski MW. Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial. BMC Cardiovasc Disord. 2023 Mar 31;23(1):176. doi: 10.1186/s12872-023-03187-x.

Reference Type: DERIVED

PMID: 37003986 (View on PubMed)

Other Identifiers

AAG-O-H-1913

Identifier Type: -

Identifier Source: org_study_id