Registry to evaluate outcomes of coronary artery disease patients treated with specific balloon catheters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.