The main objective of this randomized, multicenter, international, open-label clinical trial is to demonstrate that, in the context of percutaneous coronary intervention for complex coronary artery disease, a SeQuent® SCB interventional strategy is non-inferior to a new-generation
DES strategy in terms of a 12- and 36-month composite of Target Vessel Failure (TVF), that includes:
* cardiovascular death (CV death), * target vessel related MI (TV-MI), * clinically indicated target vessel revascularization (ci-TVR), * bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5.
Eligible subjects will be assigned in a 1:1 ratio to receive treatment of all lesions with either the SeQuent® SCB-based strategy or a DES-based strategy. The randomization will be performed prior to the index procedure once signed informed consent has been obtained and all eligibility criteria have been confirmed.
All Subjects will be followed for clinical outcomes at 3 months, 1, 2, and 3 years. A subset of 138 randomized patients will undergo control angiography after one-year clinical follow-up (+1 month). An independent core laboratory will analyze all baseline angiograms.
If, at 36 months, the non-inferiority of the SeQuent® SCB strategy compared to the DES strategy is achieved, superiority in terms of TVF and BARC Type 3-5 bleeding will be tested.
An optional extension of follow-up to 6 years may be implemented based on interim results and the joint decision of the Steering Committee and the Sponsor. Details regarding this optional extension are provided in the Clinical Investigation Plan.
Subject must be 18 years of age or older
Subject can understand risks, benefits, and treatment alternatives of receiving DCB treatment or DES and provide written informed consent before any study-related procedure
Subject should have a documented angina pectoris or silent ischemia as assessed by non-invasive testing, or functional invasive assessment, or equivalent (dyspnea, arrhythmia, ≥75% diameter stenosis without stress test at staged procedure), or unstable angina, hemodynamically stable NSTEMI and STEMI more than 48 hours after primary PCI and without residual thrombotic material
Subject must be affiliated with a social security system, where applicable
Primary PCI (acute STEMI patients)
Cardiogenic shock
Subject enrolled in an active interventional trial
Subject not able or unlikely to comply with the planned follow-ups
Parallel
PCI
DevicePCI with SeQuent® SCB
PCI
DevicePCI with DES
Composite of Target Vessel Failure (TVF) and bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5
Composite of TVF and bleeding BARC 3-5
Composite of TVF and bleeding BARC 3-5
Composite of TVF and bleeding BARC 3-5
Device-oriented Composite Endpoint (DOCE)
a composite of cardiovascular death (CV death), device failure-related myocardial infarction (MI), and clinically indicated Target Lesion Revascularization (ci-TLR)
DOCE
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