NCT04988685 SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters
| NCT ID | NCT04988685 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luzerner Kantonsspital |
| Condition | Coronary Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2021-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Florim Cuculi, MD
PRINCIPAL INVESTIGATOR
Luzerner Kantonsspital
Frequently Asked Questions
Who can join the NCT04988685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04988685 currently recruiting?
Yes, NCT04988685 is actively recruiting participants. Contact the research team at florim.cuculi@luks.ch for enrollment information.
Where is the NCT04988685 trial being conducted?
This trial is being conducted at Lucerne, Switzerland.
Who is sponsoring the NCT04988685 clinical trial?
NCT04988685 is sponsored by Luzerner Kantonsspital. The principal investigator is Florim Cuculi, MD at Luzerner Kantonsspital. The trial plans to enroll 2,000 participants.