Evaluating the Safety and Efficacy of a Coronary Stent in Older Patients with Heart Disease
Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in the Treatment of an Octo- and Nonagenerian All-Comer Patient Cohort With Coronary Artery Disease - the Cruz Senior Study
This study is testing whether a new type of heart stent is safe and effective for patients aged 80 and older with heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 80 Years to 99 Years |
| Sex | All |
| Sponsor | IHF GmbH - Institut für Herzinfarktforschung Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT04612179 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and efficacy of the SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in patients aged 80 and older with coronary artery disease. It will enroll 2000 participants across 37 sites in Germany, Switzerland, and Austria, who will undergo percutaneous coronary intervention (PCI) using the stent. The study is non-interventional, meaning treatment will follow standard medical practices without influencing physician decisions. Participants will be followed for 12 months post-procedure to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 80 years and older with significant coronary artery stenosis suitable for PCI.
Not a fit: Patients with ST-elevation myocardial infarction or those with severe hemodynamic instability will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of a specific coronary stent in elderly patients, potentially improving treatment options for this age group.
How similar studies have performed: Other studies have shown success with similar stent systems in various populations, but this specific focus on octogenarians is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written consent received from the patient or a legal repre-sentative after the information has been provided. 2. ≥ 80 years of age. 3. De-novo or re-stenotic significant stenosis in at least one cor-onary vessel. 4. Patients with NSTE-ACS, unstable angina, stable angina, silent ischemia (no limitation of the number of treated lesions and vessels: planned staged procedures are allowed within 3 months using Supraflex Cruz only). 5. Target lesion suitable for PCI with SUPRAFLEX CRUZ™ Siroli-mus eluting coronary stent system with diameter between 2.0 and 4.5 mm 6. Total lesion length should be from 6-120 mm Exclusion Criteria: 1. Patients with ST-elevation myocardial infarction (STE-ACS) 2. Hemodynamic instability or cardiogenic shock 3. Known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (DAPT) medication required by cur-rent practice 4. Any co-morbid condition with life expectancy \< 1 year or that may result in protocol non-compliance 5. Patients who are participating in another drug or device inves-tigational study, which has not reached its primary endpoint 6. Patients under judicial protection, tutorship or curatorship
Where this trial is running
Berlin
- Charité Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: David M Leistner, Prof — Charite University, Berlin, Germany
- Study coordinator: David M Leistner, Prof.
- Email: david-manuel.leistner@charite.de
- Phone: +49-(30) 450 - 513725
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.