RecruitingNot Applicable

SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters

Switzerland2,000 participantsStarted 2021-06-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * Patient is \<18 years of age * Patient unwilling or unable to provide informed consent * pregnancy and lactation * Indication for surgical revascularization

What they're measuring

Rate of target lesion failure (TLF) and target lesion revascularization (TLR)

Timeframe: at 1 year

Trial details

NCT IDNCT04988685

SponsorLuzerner Kantonsspital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Florim Cuculi, MD

+41412052134 florim.cuculi@luks.ch