RecruitingNCT04988685

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


Sponsor

Luzerner Kantonsspital

Enrollment

2,000 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • Patient is \<18 years of age
  • Patient unwilling or unable to provide informed consent
  • pregnancy and lactation
  • Indication for surgical revascularization

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Interventions

DEVICESirolimus Eluting Balloon

PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon


Locations(1)

Luzerner Heart Centre

Lucerne, Canton of Lucerne, Switzerland

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NCT04988685


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