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Coronary Artery DiseaseNCT04138238

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

An observational study of Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 26 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Supraflex Cruz Sirolimus-eluting Stent
Type of treatment
Medical device
How many people
1,200 participants
Where
26 sitesin 3 countries
Study dates
19 Feb 2020to 31 May 2022
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

26 sites in 3 countries.

26 sites in 3 countries

Germany17 sites

  • Kerckhoff Heart Center

    Bad Nauheim, 61231

  • Heart and Diabetes Center Nordrhine Westfalia

    Bad Oeynhausen, 32545

  • Segeberg Kliniken

    Bad Segeberg, 23795

  • Charité Campus Mitte

    Berlin, 10117

  • Charité Campus Benjamin Franklin

    Berlin, 12203

  • Charité Campus Virchow

    Berlin, 13353

  • St Johannes Hospital

    Dortmund, 44137

  • Herzzentrum Dresden - Universitätklinikum an der TU Dresden

    Dresden, 01307

  • Praxisklinik Dresden

    Dresden

  • HELIOS Klinikum Erfurt

    Erfurt, 99089

  • University Hospital Erlangen

    Erlangen, 35392

  • Elizabeth Krankenhaus

    Essen, 45138

  • UKSH

    Kiel, 24105

  • Universität Leipzig - Herzzentrum

    Leipzig, 04289

  • Städtische Kliniken Neuss, Lukaskrankenhaus

    Neuss, 41464

  • Universitätsklinikum

    Regensburg, 93053

  • Klinikum Wilhelmshaven

    Wilhelmshaven, 26389

Other trials in Germany

France6 sites

  • Centre Hospitalier Haguenau

    Haguenau, 67500

  • Hôpital Privé Jacques Cartier

    Massy, 91300

  • CHRU de Montpellier

    Montpellier, 34295

  • Hôpital Privé Claude Galien

    Quincy-sous-Sénart, 91480

  • Clinique Saint Hilaire

    Rouen, 76000

  • CHU de Toulouse - Rangueil

    Toulouse, 31059

Other trials in France

Switzerland3 sites

  • University and Hospital Fribourg

    Fribourg, 1700

  • Kantonsspital St. Gallen

    Sankt Gallen, 9000

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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.

Being tested
Supraflex Cruz Sirolimus-eluting Stent
Keywords
Supraflex Cruz, Sirolimus-eluting Stent, High Bleeding Risk, Coronary Artery Disease, Arteriosclerosis, Myocardial Ischemia, Vascular Diseases, Coronary Intervention, Observational Registry, Ultra-thin Strut Biodegradable Polymer
Medical subject headings
Coronary Artery Disease, Arteriosclerosis, Myocardial Ischemia, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supraflex Cruz Sirolimus-eluting StentDevice

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

Study groups in NCT04138238
Study groupRoleWhat they receive
Supraflex Cruz Sirolimus-eluting StentNot described
Receives: Device: Supraflex Cruz Sirolimus-eluting Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 months

Secondary outcomes (12)

  1. All death, cardiovascular death and non-cardiovascular death

    Measured: 6 months and 12 months

  2. All myocardial infarction (MI)

    Measured: 6 months and 12 months

  3. Target vessel MI and MI not clearly attributable to non-target vessel

    Measured: 6 months and 12 months

  4. Clinically indicated target lesion revascularization (TLR)

    Measured: 6 months and 12 months

  5. All target lesion revascularization (TLR)

    Clinically and non-clinically indicated target lesion revascularization (TLR)

    Measured: 6 months and 12 months

  6. All target vessel revascularization (TVR)

    Clinically and non-clinically indicated target vessel revascularization (TVR)

    Measured: 6 months and 12 months

  7. All revascularization

    Any revascularization, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR

    Measured: 6 months and 12 months

  8. Stent thrombosis (ARC2)

    Measured: 6 months and 12 months

  9. Device success

    Defined as deployment of the stents without system failure or device-related complication

    Measured: Up to 1 Day

  10. Lesion success

    Defined as the attainment of < 50% residual stenosis of the target lesions post-PCI

    Measured: Up to 1 Day

  11. Procedure success

    Defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay

    Measured: Up to 7 Days

  12. Major bleeding (BARC 3 to 5) in the HBR population

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2019
  2. Study start19 Feb 2020
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04138238
Sponsor's protocol ID
SMT CT 2019-20/108
Status last verified
Jul 2023
First submitted
14 Oct 2019
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 26 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany, France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Oriented Composite Endpoint (DOCE) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04138238.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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