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Taking people in SwitzerlandNo phase

Observes how sirolimus or paclitaxel balloon catheters work in coronary artery disease patients

Follows adults with coronary artery disease treated with sirolimus or paclitaxel balloon catheters.

Plain-language title generated from the registry record
Registry title: SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters

Key facts

Where
Lucerne, SwitzerlandSee the site

Where in Switzerland

  • Luzerner Heart CentreLucerne, SwitzerlandTaking people

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
Luzerner Kantonsspital
Trial code
NCT04988685
Record updated
29 October 2024
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Indication for surgical revascularization; Patient is <18 years of age; Patient unwilling or unable to provide informed consent; pregnancy and lactation.

ClinicalTrials.gov NCT04988685