SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLuzerner Kantonsspital

About this trial

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

Qualifiers

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).

Disqualifiers

Patient is <18 years of age

Patient unwilling or unable to provide informed consent

pregnancy and lactation

Indication for surgical revascularization

Trial design

Treatments tested in this trial

  • Sirolimus Eluting Balloon

Treatment groups

2,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

Luzerner Kantonsspital

Lead sponsor

University Hospital, Geneva

Collaborator