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

July 11, 2023 updated by: Sahajanand Medical Technologies Limited

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Haguenau, France, 67500
        • Centre Hospitalier Haguenau
      • Massy, France, 91300
        • Hôpital Privé 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
        • Charité Campus Mitte
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin
      • Berlin, Germany, 13353
        • Charite 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Device Oriented Composite Endpoint (DOCE)
Time Frame: 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)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All death, cardiovascular death and non-cardiovascular death
Time Frame: 6 months and 12 months
6 months and 12 months
All myocardial infarction (MI)
Time Frame: 6 months and 12 months
6 months and 12 months
Target vessel MI and MI not clearly attributable to non-target vessel
Time Frame: 6 months and 12 months
6 months and 12 months
Clinically indicated target lesion revascularization (TLR)
Time Frame: 6 months and 12 months
6 months and 12 months
All target lesion revascularization (TLR)
Time Frame: 6 months and 12 months
Clinically and non-clinically indicated target lesion revascularization (TLR)
6 months and 12 months
All target vessel revascularization (TVR)
Time Frame: 6 months and 12 months
Clinically and non-clinically indicated target vessel revascularization (TVR)
6 months and 12 months
All revascularization
Time Frame: 6 months and 12 months
Any revascularization, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR
6 months and 12 months
Stent thrombosis (ARC2)
Time Frame: 6 months and 12 months
6 months and 12 months
Device success
Time Frame: Up to 1 Day
Defined as deployment of the stents without system failure or device-related complication
Up to 1 Day
Lesion success
Time Frame: Up to 1 Day
Defined as the attainment of < 50% residual stenosis of the target lesions post-PCI
Up to 1 Day
Procedure success
Time Frame: Up to 7 Days
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
Time Frame: 6 months and 12 months
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sahajanand Medical Technologies Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cardiovascular European Research Center (CERC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof. Christoph K Naber, PD. Dr. Med., Klinikum Wilhelmshaven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings