Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent

Study Overview
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Brief Summary
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This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.

Official Title
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Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Sirolimus-eluting Coronary Stent System in the Treatment of All-comer Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Supraflex Cruz Sirolimus-eluting Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years old De novo or re-stenotic significant stenosis in at least one native coronary artery Patients with silent ischemia, stable angina, unstable angina or non-STEMI eligible for PCI (no limitation of the number of treated lesions and vessels, except higher tercile of Syntax score assessed by the site) Target lesions suitable for PCI with Drug-eluting Stent (DES) diameter between 2.00 and 4.50 mm Total lesion length should be from 15 to 120 mm Patient is willing and capable to sign the written informed consent and comply with all requirements of the registry Planned staged procedures are allowed within 3 months using Supraflex Cruz stent only Exclusion Criteria: SYNTAX Score > 32 Hemodynamic instability or cardiogenic shock 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 current practice Subject is pregnant, nursing or is a woman with child-bearing potential Any co-morbid condition with life expectancy < 1 year or that may result in protocol non-compliance Patients who are participating in another drug or device investigational study, which has not reached its primary endpoint Patients under judicial protection, tutorship or curatorship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supraflex Cruz Sirolimus-eluting Stent<br> | Device: Supraflex Cruz Sirolimus-eluting Stent<br>* Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Oriented Composite Endpoint (DOCE) | DOCE is a composite of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically-driven target lesion revascularization (TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death, cardiovascular death and non-cardiovascular death |  | 6 months and 12 months | 
| All myocardial infarction (MI) |  | 6 months and 12 months | 
| Target vessel MI and MI not clearly attributable to non-target vessel |  | 6 months and 12 months | 
| Clinically indicated target lesion revascularization (TLR) |  | 6 months and 12 months | 
| All target lesion revascularization (TLR) | Clinically and non-clinically indicated target lesion revascularization (TLR) | 6 months and 12 months | 
| All target vessel revascularization (TVR) | Clinically and non-clinically indicated target vessel revascularization (TVR) | 6 months and 12 months | 
| All revascularization | Any revascularization, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR | 6 months and 12 months | 
| Stent thrombosis (ARC2) |  | 6 months and 12 months | 
| Device success | Defined as deployment of the stents without system failure or device-related complication | Up to 1 Day | 
| Lesion success | Defined as the attainment of < 50% residual stenosis of the target lesions post-PCI | Up to 1 Day | 
| Procedure success | Defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay | Up to 7 Days | 
| Major bleeding (BARC 3 to 5) in the HBR population |  | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraflex Cruz, Sirolimus-eluting Stent, High Bleeding Risk, Coronary Artery Disease, Arteriosclerosis, Myocardial Ischemia, Vascular Diseases, Coronary Intervention, Observational Registry, Ultra-thin Strut Biodegradable Polymer