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

Sahajanand Medical Technologies Limited26 sites in 3 countries1,200 target enrollmentFebruary 19, 2020

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Sahajanand Medical Technologies Limited
Enrollment: 1200
Locations: 26
Primary Endpoint: Device Oriented Composite Endpoint (DOCE)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 19, 2020

End Date

May 31, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sahajanand Medical Technologies Limited

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Device Oriented Composite Endpoint (DOCE)

Time Frame: 12 months

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)

Secondary Outcomes

All death, cardiovascular death and non-cardiovascular death(6 months and 12 months)
Target vessel MI and MI not clearly attributable to non-target vessel(6 months and 12 months)
All myocardial infarction (MI)(6 months and 12 months)
All target lesion revascularization (TLR)(6 months and 12 months)
All target vessel revascularization (TVR)(6 months and 12 months)
Stent thrombosis (ARC2)(6 months and 12 months)
Lesion success(Up to 1 Day)
Procedure success(Up to 7 Days)
Major bleeding (BARC 3 to 5) in the HBR population(6 months and 12 months)
All revascularization(6 months and 12 months)
Clinically indicated target lesion revascularization (TLR)(6 months and 12 months)
Device success(Up to 1 Day)