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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Myocardial Ischaemia
• Intervention / Treatment: Device: SeQuent® SCB drug-coated balloon catheter

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.

• Study Type: Observational
• Enrollment (Estimated): 1302

Contacts and Locations

Study Locations

• Germany
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Universitätsklinikum Jena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
ischemia driven target lesion revascularization (TLR)		at 12 months
ischemia driven target lesion revascularization (TLR)		at 24 months
all-cause death, cardiac death		at 12 months
all-cause death, cardiac death		at 24 months
all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)		at 12 months
all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)		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	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	at 24 months
Dual Antiplatelet Therapy (DAPT) compliance		at 4 weeks
Dual Antiplatelet Therapy (DAPT) compliance		at 3 months
Probable or definite stent-thrombosis of In-stent treated lesions		accumulated at 12 months
Probable or definite stent-thrombosis of In-stent treated lesions		accumulated at 24 months
Procedural success	final diameter stenosis < 30 % without flow-limiting dissections	immediately after procedure
Bleeding complications according to the Bleeding Academic Research Consortium (BARC)		accumulated at 3 months
Bleeding complications according to the Bleeding Academic Research Consortium (BARC)		accumulated at 12 months
Bleeding complications according to the Bleeding Academic Research Consortium (BARC)		accumulated at 24 months

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Sylvia Otto, MD, Universitätsklinikum Jena - Klinik für Innere Medizin I

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Myocardial Ischemia; drug-coated balloon catheter
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AAG-O-H-1913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No