SIROOP Registry - a Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated with SIROlimus or Paclitaxel Eluting Balloon Catheters
Luzerner Kantonsspital
2,000 participants
Jun 1, 2021
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- Patient is \<18 years of age
- Patient unwilling or unable to provide informed consent
- pregnancy and lactation
- Indication for surgical revascularization
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Interventions
PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04988685