Status:
COMPLETED
Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent
Lead Sponsor:
Sahajanand Medical Technologies Limited
Collaborating Sponsors:
European Cardiovascular Research Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04138238
Start Date
February 19 2020
End Date
May 31 2022
Last Update
July 12 2023
Active Locations (26)
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1
Centre Hospitalier Haguenau
Haguenau, France, 67500
2
Hôpital Privé Jacques Cartier
Massy, France, 91300
3
CHRU de Montpellier
Montpellier, France, 34295
4
Hôpital Privé Claude Galien
Quincy-sous-Sénart, France, 91480