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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Switzerland
Luzerner Heart Centre
RECRUITING
Lucerne
Contact Information
Primary
Florim Cuculi, MD
florim.cuculi@luks.ch
+41412052134
Backup
Matthias Bossard, MD
matthias.bossard@luks.ch
+41412051477
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 2000
Treatments
Treatment
The project ́s main goal is to collect baseline, clinical and procedural data as well as to assess angiographic and clinical outcomes of CAD patients treated with contemporary DCBs.
Sponsors
Leads: Luzerner Kantonsspital
Collaborators: University Hospital, Geneva

This content was sourced from clinicaltrials.gov