NCT04612179Completed
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2025
Brief summary (registry, in English)
Prospective, multi-centre, open-label, single-armed, non-interventional observational clinical investigation designed to enrol 2000 octo- and nonagenerian all-comer patients with coro-nary artery disease in up to 37 sites in Germany, Switzerland and Austria. Patients underwent PCI using at least one Supraflex Cruz Sirolimus Eluting stent as per current practice and will be followed up for 12 months.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2017 (actual)
- First submitted
- 30 Oct 2020
- Start date
- 23 Jun 2021
- Primary completion date
- 12 Jun 2025
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Diseases
- Coronary artery disease
- NCT number
- NCT04612179
What you commit to
- Study type: Observational
- Participants enrolled: 2017
- From 23 Jun 2021 to the primary completion date, 12 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are participating in another drug or device inves-tigational study, which has not reached its primary endpoint
Other illness
- Patients with ST-elevation myocardial infarction (STE-ACS)
- 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
- Any co-morbid condition with life expectancy \< 1 year or that may result in protocol non-compliance
Other
- Hemodynamic instability or cardiogenic shock
- Patients under judicial protection, tutorship or curatorship
Who the study is looking for
- Written consent received from the patient or a legal repre-sentative after the information has been provided.
- ≥ 80 years of age.
- De-novo or re-stenotic significant stenosis in at least one cor-onary vessel.
- 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).
- Target lesion suitable for PCI with SUPRAFLEX CRUZ™ Siroli-mus eluting coronary stent system with diameter between 2.0 and 4.5 mm
- Total lesion length should be from 6-120 mm
Age in the registry: 80 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.