Last updated on August 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Coronary heart disease | Coronary Artery Disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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