Registry for patients treated with EucaLimus coronary stents
Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease: a PMCF Study.
OrbusNeich · NCT06621524
This study is tracking how well the EucaLimus stent works and its safety for people with coronary heart disease over three years after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 251 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OrbusNeich (industry) |
| Locations | 5 sites (Liberec and 4 other locations) |
| Trial ID | NCT06621524 on ClinicalTrials.gov |
What this trial studies
This observational registry collects post-marketing surveillance data on patients with coronary heart disease who are treated with the EucaLimus sirolimus-eluting PTCA stent during routine clinical care. The study involves approximately 251 patients across 5-10 centers in Europe and Asia, who will be followed for three years to assess the long-term safety and performance of the stent. Follow-up assessments occur at multiple time points, including immediately post-procedure and at 30 days, 6 months, 12 months, 24 months, and 36 months, through telephone contact or hospital visits.
Who should consider this trial
Good fit: Ideal candidates are consecutive patients with coronary heart disease who are intended to be treated with the EucaLimus stent as part of routine clinical care.
Not a fit: Patients with a life expectancy of less than one year or those who refuse participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of the EucaLimus stent, potentially improving treatment strategies for coronary artery disease.
How similar studies have performed: Other studies involving post-marketing registries for coronary stents have shown success in assessing long-term outcomes, indicating that this approach is validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry. Exclusion Criteria: * Patients are excluded from registration if ANY of the following conditions apply: * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned * A life expectancy of \<1year * Explicit refusal of participation in the registry
Where this trial is running
Liberec and 4 other locations
- Krajska nemocnice Liberec — Liberec, Czech Republic (RECRUITING)
- Motol University Hospital — Prague, Czech Republic (RECRUITING)
- Institut Jantung Negara — Kuala Lumpur, Malaysia (RECRUITING)
- Bellvitge University Hospital — L'Hospitalet de Llobregat, Catalonia, Spain (RECRUITING)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Josep Gomez-Lara, MD, PhD — Bellvitge University Hospital
- Study coordinator: Jenny Chong, BS
- Email: jchong@orbusneich.com
- Phone: +6012 298-0651
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.
Conditions: Coronary Arterioscleroses, Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases, Drug-Coated Stent