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

Sahajanand Medical Technologies

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Supraflex Cruz Sirolimus-eluting Stent

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04138238

SMT CT 2019-20/108

Details and patient eligibility

About

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.

Enrollment: 1,200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥ 18 years old
2. De novo or re-stenotic significant stenosis in at least one native coronary artery
3. 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)
4. Target lesions suitable for PCI with Drug-eluting Stent (DES) diameter between 2.00 and 4.50 mm
5. Total lesion length should be from 15 to 120 mm
6. Patient is willing and capable to sign the written informed consent and comply with all requirements of the registry
7. Planned staged procedures are allowed within 3 months using Supraflex Cruz stent only

Exclusion criteria

1. SYNTAX Score > 32
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 current practice
4. Subject is pregnant, nursing or is a woman with child-bearing potential
5. Any co-morbid condition with life expectancy < 1 year or that may result in protocol non-compliance
6. Patients who are participating in another drug or device investigational study, which has not reached its primary endpoint
7. Patients under judicial protection, tutorship or curatorship

Trial design

1,200 participants in 1 patient group

Supraflex Cruz Sirolimus-eluting Stent

Treatment:

Device: Supraflex Cruz Sirolimus-eluting Stent