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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Supraflex Cruz Sirolimus-eluting Stent

• Registration Number: NCT04138238
• Lead Sponsor: Sahajanand Medical Technologies Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2020-02-19
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Supraflex Cruz Sirolimus-eluting Stent	Supraflex Cruz Sirolimus-eluting Stent	-

Primary Outcome Measures

Name	Time	Method
Device Oriented Composite Endpoint (DOCE)	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 Outcome Measures

Name	Time	Method
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	Clinically and non-clinically indicated target lesion revascularization (TLR)
All target vessel revascularization (TVR)	6 months and 12 months	Clinically and non-clinically indicated target vessel revascularization (TVR)
Stent thrombosis (ARC2)	6 months and 12 months
Lesion success	Up to 1 Day	Defined as the attainment of \< 50% residual stenosis of the target lesions post-PCI
Procedure success	Up to 7 Days	Defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay
Major bleeding (BARC 3 to 5) in the HBR population	6 months and 12 months
All revascularization	6 months and 12 months	Any revascularization, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR
Clinically indicated target lesion revascularization (TLR)	6 months and 12 months
Device success	Up to 1 Day	Defined as deployment of the stents without system failure or device-related complication

Trial Locations

Locations (26)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France

Kerckhoff Heart Center; 🇩🇪 Bad Nauheim, Germany

Clinique Saint Hilaire; 🇫🇷 Rouen, France

Segeberg Kliniken; 🇩🇪 Bad Segeberg, Germany

Heart and Diabetes Center Nordrhine Westfalia; 🇩🇪 Bad Oeynhausen, Germany

Charité Campus Mitte; 🇩🇪 Berlin, Germany

Charité Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Charité Campus Virchow; 🇩🇪 Berlin, Germany

St Johannes Hospital; 🇩🇪 Dortmund, Germany

Herzzentrum Dresden - Universitätklinikum an der TU Dresden; 🇩🇪 Dresden, Germany

University Hospital Erlangen; 🇩🇪 Erlangen, Germany

Elizabeth Krankenhaus; 🇩🇪 Essen, Germany

Klinikum Wilhelmshaven; 🇩🇪 Wilhelmshaven, Germany

UKSH; 🇩🇪 Kiel, Germany

Universität Leipzig - Herzzentrum; 🇩🇪 Leipzig, Germany

Städtische Kliniken Neuss, Lukaskrankenhaus; 🇩🇪 Neuss, Germany

Universitätsklinikum; 🇩🇪 Regensburg, Germany

University and Hospital Fribourg; 🇨🇭 Fribourg, Switzerland

Kantonsspital St. Gallen; 🇨🇭 Saint Gallen, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Centre Hospitalier Haguenau; 🇫🇷 Haguenau, France

CHRU de Montpellier; 🇫🇷 Montpellier, France

CHU de Toulouse - Rangueil; 🇫🇷 Toulouse, France

Praxisklinik Dresden; 🇩🇪 Dresden, Germany

HELIOS Klinikum Erfurt; 🇩🇪 Erfurt, Germany