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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Supraflex Cruz Sirolimus-eluting Stent

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• France
  • Haguenau, France, 67500
    • Centre Hospitalier Haguenau
  • Massy, France, 91300
    • Hopital Prive Jacques Cartier
  • Montpellier, France, 34295
    • CHRU de Montpellier
  • Quincy-sous-Sénart, France, 91480
    • Hôpital Privé Claude Galien
  • Rouen, France, 76000
    • Clinique Saint Hilaire
  • Toulouse, France, 31059
    • CHU de Toulouse - Rangueil
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Heart Center
  • Bad Oeynhausen, Germany, 32545
    • Heart and Diabetes Center Nordrhine Westfalia
  • Bad Segeberg, Germany, 23795
    • Segeberg Kliniken
  • Berlin, Germany, 10117
    • Charite Campus Mitte
  • Berlin, Germany, 12203
    • Charite Campus Benjamin Franklin
  • Berlin, Germany, 13353
    • Charité Campus Virchow
  • Dortmund, Germany, 44137
    • St Johannes Hospital
  • Dresden, Germany, 01307
    • Herzzentrum Dresden - Universitätklinikum an der TU Dresden
  • Dresden, Germany
    • Praxisklinik Dresden
  • Erfurt, Germany, 99089
    • HELIOS Klinikum Erfurt
  • Erlangen, Germany, 35392
    • University Hospital Erlangen
  • Essen, Germany, 45138
    • Elizabeth Krankenhaus
  • Kiel, Germany, 24105
    • UKSH
  • Leipzig, Germany, 04289
    • Universität Leipzig - Herzzentrum
  • Neuss, Germany, 41464
    • Städtische Kliniken Neuss, Lukaskrankenhaus
  • Regensburg, Germany, 93053
    • Universitätsklinikum
  • Wilhelmshaven, Germany, 26389
    • Klinikum Wilhelmshaven
• Switzerland
  • Fribourg, Switzerland, 1700
    • University and Hospital Fribourg
  • Saint Gallen, Switzerland, 9000
    • Kantonsspital St. Gallen
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All-comer patients affected by silent ischemia, stable angina or acute coronary syndrome (unstable angina and non-STEMI), who qualify for percutaneous coronary intervention (PCI), 400 patients of the population must qualify for HBR criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Supraflex Cruz Sirolimus-eluting Stent	Device: Supraflex Cruz Sirolimus-eluting Stent; Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sahajanand Medical Technologies Limited
• Collaborators: Cardiovascular European Research Center (CERC)
• Investigators: Principal Investigator: Prof. Christoph K Naber, PD. Dr. Med., Klinikum Wilhelmshaven

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Vascular Diseases; Coronary Artery Disease; High Bleeding Risk; Arteriosclerosis; Supraflex Cruz; Sirolimus-eluting Stent; Myocardial Ischemia; Coronary Intervention; Observational Registry; Ultra-thin Strut Biodegradable Polymer
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: SMT CT 2019-20/108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No