BASKET BALL - a Prospective, Multicenter, International, Open-label, Randomized Clinical Trial Comparing the Sirolimus-DCB Strategy vs. DES Strategy in de Novo High-risk Patients
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
⁃ Subject must have at least one of the high clinical or anatomical risk features:
⁃ High clinical risk, defined as:
• DM on treatment (insulin or oral antidiabetic agents), or
• At least 75 years of age, or
• CKD (eGFR \<60 mL/min/1.73 m2), or
• Treated for ACS (unstable angina, hemodynamically stable NSTEMI, hemodynamically stable STEMI more than 48 hours after uneventful primary PCI and without residual thrombotic material), or
• High bleeding risk (defined by Academic Research Consortium criteria - ARC HBR)
⁃ OR
⁃ High anatomical risk lesions requiring treatment as follows:
• Multivessel treatment (two or three vessels)
• True bifurcation with side branch involvement
• Long lesions (≥36 mm)
• Lesion likely requiring calcium modification
⁃ In the case of multivessel (MV) disease, multiple vessels can be treated provided that all lesions are amenable to treatment with either DCB or DES and vessel size at the site of the lesion is \>2.0 mm by visual assessment.
⁃ The trial does not restrict the number of target lesions. However, the operator should determine that all target lesions intended to be treated must be suitable for treatment with either DES or DCB. For patients randomized to the DCB arm, the likelihood of requiring provisional stenting must be assessed as less than 30% for each lesion requiring treatment.