Related Experiment Video
Updated: Jun 19, 2026
04:30
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
25.5K
Safety and efficacy of the latest generation biodegradable polymer-coated ultrathin sirolimus-eluting stent in the
David M Leistner1,2, Rajiv Rampat3, Michael Haude4
1Department of Cardiology, Angiology and Intensive Care Medicine, Goethe University Hospital, Frankfurt, Germany.
Minerva Cardiology and Angiology
|May 28, 2024
Summary
The Supraflex Cruz sirolimus-eluting stent (SES) is safe and effective for percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients. This study confirms favorable outcomes in an all-comer population, including complex HBR cases.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- The Supraflex Cruz sirolimus-eluting stent (SES) is a new ultrathin device for percutaneous coronary intervention (PCI).
- It has shown promising early healing properties, making it a potential option for high bleeding risk (HBR) patients.
Purpose of the Study:
- To evaluate the safety and efficacy of the Supraflex Cruz SES in a large cohort of unselected patients.
- Specifically, to assess its performance in patients with high bleeding risk (HBR).
Main Methods:
- A prospective, multi-center, open-label registry enrolled patients undergoing PCI.
- Patients were stratified into non-HBR and HBR groups.
- The primary endpoint was a device-oriented composite endpoint (DOCE) at 12 months, with predefined non-inferiority aims against historical trials.
Main Results:
- 1203 patients were enrolled, with 38.7% classified as HBR.
- The DOCE occurred in 5.8% of the total cohort (8.1% in HBR vs. 4.4% in non-HBR).
- The study met non-inferiority criteria for both HBR and non-HBR groups compared to relevant historical trials.
Conclusions:
- Percutaneous coronary intervention (PCI) using the Supraflex Cruz SES demonstrates favorable clinical outcomes.
- This includes complex patients with high bleeding risk (HBR).
- The registry confirms the device's utility in an all-comer population.
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