The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.
Subject >18 years of age
Patients with significant acute or chronic coronary de-novo lesions or ISR lesions requiring treatment using PCI
Treatment with at least one DCB (device choice at the operator's discretion) In case of a patient with lesions treated at different procedural time, lesions will be separately collected and documented
Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).
Patient is <18 years of age
Patient unwilling or unable to provide informed consent
pregnancy and lactation
Indication for surgical revascularization
This registry will recruit consecutive patients treated with either DCB alone or a hybrid strategy (metallic stent plus DCB). Ideally any patient treated with a DCB will be included in the present registry, either presenting with a de-novo coronary lesion (either elective or urgent procedure), with a ST or ISR.
Cohort
Prospective
Sirolimus Eluting Balloon
DevicePTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon
Rate of target lesion failure (TLF) and target lesion revascularization (TLR)
Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) (including new MI, TLR or cardiovascular death)
Rate of MACE
Rate of new MI (NSTEMI / STEMI)
Rate of TIA or stroke
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Luzerner Kantonsspital
Lead sponsor
University Hospital, Geneva
Collaborator
