Registry to evaluate outcomes of coronary artery disease patients treated with specific balloon catheters
SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters
This study looks at how well certain drug-coated balloons work for patients with coronary artery disease who have had a specific heart procedure, to see how they help with recovery and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Luzerner Kantonsspital Academic / other |
| Locations | 1 site (Lucerne, Canton of Lucerne) |
| Trial ID | NCT04988685 on ClinicalTrials.gov |
What this trial studies
The SIROOP Registry aims to collect and analyze clinical and procedural data from patients with coronary artery disease who have undergone percutaneous coronary intervention (PCI) using sirolimus or paclitaxel coated drug-coated balloons (DCBs). This observational study will assess both short and long-term clinical outcomes, including complications and effectiveness of the treatments across various patient cohorts. The registry will also explore optimal strategies for lesion preparation and the impact of different antithrombotic regimens on patient outcomes. Data will be collected retrospectively and prospectively to evaluate the performance of DCBs in different clinical settings.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with significant coronary lesions requiring PCI treatment using drug-coated balloons.
Not a fit: Patients under 18 years, those unwilling to provide informed consent, or those requiring surgical revascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for coronary artery disease, leading to better patient outcomes and reduced complications.
How similar studies have performed: Other studies have shown promising results with drug-coated balloons in treating coronary artery disease, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lucerne, Canton of Lucerne
- Luzerner Heart Centre — Lucerne, Canton of Lucerne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Florim Cuculi, MD — Luzerner Kantonsspital
- Study coordinator: Florim Cuculi, MD
- Email: florim.cuculi@luks.ch
- Phone: +41412052134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.