Evaluation of Orsiro and Promus stents in heart procedures
Systematic Post-Implementation Evaluation of Stents
This study is testing whether a thinner stent called Orsiro works better and is more cost-effective than a thicker stent called Promus for heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT05584280 on ClinicalTrials.gov |
What this trial studies
This project aims to assess the differences in healthcare processes and cost-effectiveness between the ultrathin Orsiro stent and the thicker Promus stent during percutaneous coronary interventions (PCI). Participating cardiac catheterization laboratories in Västra Götaland, Sweden, will randomly assign one of the two stents to be the most accessible option each week. Patients will be treated according to local guidelines, and outcomes will be monitored through various registries to evaluate the effectiveness and safety of each stent type.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing PCI at hospitals participating in the study.
Not a fit: Patients not undergoing PCI or those treated at non-participating hospitals may not benefit from this study.
Why it matters
Potential benefit: If successful, this evaluation could lead to improved stent selection and better patient outcomes in myocardial ischemia treatments.
How similar studies have performed: Previous studies have indicated potential advantages of ultrathin stents, suggesting that this evaluation could provide valuable insights into their effectiveness compared to thicker alternatives.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing PCI at any hospital participating in the study Exclusion Criteria: * None
Where this trial is running
Gothenburg
- Kardiologen — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Björn Redfors, MD, PhD
- Email: bjorn.redfors@wlab.gu.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.