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Completed

NCT Number: NCT04138238

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Haguenau, Haguenau, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Supraflex Cruz Sirolimus-eluting Stent

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

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

    Time frame: 6 months and 12 months

  2. All myocardial infarction (MI)

    Time frame: 6 months and 12 months

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

    Time frame: 6 months and 12 months

  4. Clinically indicated target lesion revascularization (TLR)

    Time frame: 6 months and 12 months

  5. All target lesion revascularization (TLR)

    Time frame: 6 months and 12 months

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

  6. All target vessel revascularization (TVR)

    Time frame: 6 months and 12 months

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

  7. All revascularization

    Time frame: 6 months and 12 months

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

  8. Stent thrombosis (ARC2)

    Time frame: 6 months and 12 months

  9. Device success

    Time frame: Up to 1 Day

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

  10. Lesion success

    Time frame: Up to 1 Day

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

  11. Procedure success

    Time frame: Up to 7 Days

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

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

    Time frame: 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Sahajanand Medical Technologies Limited

Industry

Collaborators

  • European Cardiovascular Research Center

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2019
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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