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SIROOP Registry - a Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated with SIROlimus or Paclitaxel Eluting Balloon Catheters

Launched by LUZERNER KANTONSSPITAL · Jul 25, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The SIROOP Registry is a clinical trial designed to study the outcomes of patients with coronary artery disease who are treated with special balloon catheters that release medication. These balloons, called sirolimus or paclitaxel-coated drug-coated balloons (DCBs), are used during a procedure called percutaneous coronary intervention (PCI) to help open up blocked arteries. The trial aims to gather information about patients' health and how well these treatments work, comparing results across different groups of patients based on their specific conditions.

To participate in this study, individuals must be at least 18 years old and have significant blockages in their coronary arteries that need treatment. Participants will need to provide consent to join the study. Throughout the trial, researchers will track patients' progress and health outcomes after receiving treatment with the drug-coated balloons. This information will help doctors understand the effectiveness of these treatments in various situations and improve care for future patients with similar heart conditions.

Gender

ALL

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

About Luzerner Kantonsspital

Luzerner Kantonsspital (LUKS) is a leading academic hospital located in Lucerne, Switzerland, dedicated to providing high-quality healthcare and advancing medical research. As a prominent clinical trial sponsor, LUKS is committed to fostering innovation in medical treatments and therapies through rigorous clinical studies. The institution emphasizes collaboration with multidisciplinary teams of healthcare professionals, researchers, and academic partners to ensure that its trials adhere to the highest ethical standards and regulatory requirements. With a focus on improving patient outcomes, LUKS leverages its state-of-the-art facilities and expertise to contribute significantly to the advancement of medical science.

Locations

Lucerne, , Switzerland

Patients applied

0 patients applied

Trial Officials

Florim Cuculi, MD

Principal Investigator

Luzerner Kantonsspital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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