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

NCT04470934 | Active Not Recruiting

• 1 other identifier: AAG-O-H-1913
• Study Type: observational
• Target: 1,302
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease; Myocardial Ischaemia

Keywords

Coronary Artery Disease; Myocardial Ischemia; drug-coated balloon catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Target Lesion Failure (TLF)

  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

Interventions

SeQuent® SCB drug-coated balloon catheter DEVICE

treatment of coronary artery disease with SeQuent® SCB of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (1)

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Related Publications (1)

• 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.

  PMID: 37003986 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Sylvia Otto, MD

  Universitätsklinikum Jena - Klinik für Innere Medizin I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 14, 2020
• Study Start: April 30, 2021
• Primary Completion: January 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)