NCT04138238

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
3 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 19, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

October 14, 2019

Last Update Submit

July 11, 2023

Conditions

Coronary Artery Disease

Keywords

Supraflex CruzSirolimus-eluting StentHigh Bleeding RiskCoronary Artery DiseaseArteriosclerosisMyocardial IschemiaVascular DiseasesCoronary InterventionObservational RegistryUltra-thin Strut Biodegradable Polymer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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)

    6 months and 12 months

  • +7 more secondary outcomes

Study Arms (1)

Supraflex Cruz Sirolimus-eluting Stent

Device: Supraflex Cruz Sirolimus-eluting Stent

Interventions

Supraflex Cruz Sirolimus-eluting StentDEVICE

Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care

Supraflex Cruz Sirolimus-eluting Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Centre Hospitalier Haguenau

Haguenau, 67500, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

CHRU de Montpellier

Montpellier, 34295, France

Location

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Clinique Saint Hilaire

Rouen, 76000, France

Location

CHU de Toulouse - Rangueil

Toulouse, 31059, France

Location

Kerckhoff Heart Center

Bad Nauheim, 61231, Germany

Location

Heart and Diabetes Center Nordrhine Westfalia

Bad Oeynhausen, 32545, Germany

Location

Segeberg Kliniken

Bad Segeberg, 23795, Germany

Location

Charité Campus Mitte

Berlin, 10117, Germany

Location

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Charité Campus Virchow

Berlin, 13353, Germany

Location

St Johannes Hospital

Dortmund, 44137, Germany

Location

Herzzentrum Dresden - Universitätklinikum an der TU Dresden

Dresden, 01307, Germany

Location

Praxisklinik Dresden

Dresden, Germany

Location

HELIOS Klinikum Erfurt

Erfurt, 99089, Germany

Location

University Hospital Erlangen

Erlangen, 35392, Germany

Location

Elizabeth Krankenhaus

Essen, 45138, Germany

Location

UKSH

Kiel, 24105, Germany

Location

Universität Leipzig - Herzzentrum

Leipzig, 04289, Germany

Location

Städtische Kliniken Neuss, Lukaskrankenhaus

Neuss, 41464, Germany

Location

Universitätsklinikum

Regensburg, 93053, Germany

Location

Klinikum Wilhelmshaven

Wilhelmshaven, 26389, Germany

Location

University and Hospital Fribourg

Fribourg, 1700, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9000, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery DiseaseArteriosclerosisMyocardial IschemiaVascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArterial Occlusive Diseases

Study Officials

  • Prof. Christoph K Naber, PD. Dr. Med.

    Klinikum Wilhelmshaven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 24, 2019

Study Start

February 19, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(3)DE(17)FR(6)