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Completed

NCT Number: NCT03567733

Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study

This prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent.

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Key information

Conditions

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

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Garcia de Orta, Almada, Portugal

Loading trial locations.

About this study

This prospective registry is intended to analyze clinical outcomes in elderly patients treated with XIENCE Sierra stent and in pre-established subgroups (stable and unstable coronary artery disease).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age> 75 years.
  • With indication of percutaneous revascularization.
  • Presence of de novo coronary artery lesions located in a native coronary artery.
  • Informed consent signed

Exclusion criteria

  • Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention)
  • Cardiac arrest before the PCI
  • Life expectancy of the patient under 1 year
  • Participation in another study with a drug or device in clinical research
  • Clinical decision that excludes the use of drug-eluting stents
  • Confirmed allergy to aspirin and / or thienopyridines.

Treatment and study plan

XIENCE Sierra

Device

Percutaneous coronary intervention

Primary outcomes

  1. Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). .

    Time frame: 12 month

    The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).

    .

  2. Efficacy.The incidence of clinically driven target lesion revascularization (TLR).

    Time frame: 12 month

    The incidence of clinically driven target lesion revascularization (TLR).

Secondary outcomes

  1. All death.

    Time frame: 12 month

    All death.

    Systemic embolism, Major bleeding event (BARC ≥ 2)

  2. Cardiac death.

    Time frame: 12 month

    Cardiac death.

  3. Target Vessel revascularization.

    Time frame: 12 month

    Target Vessel revascularization.

  4. Target lesion revascularization.

    Time frame: 12 month

    Target lesion revascularization.

  5. Stent thrombosis (ARC definite/probable).

    Time frame: 12 month

    Stent thrombosis (ARC definite/probable).

  6. Major bleeding event (BARC type 2-5).

    Time frame: 12 month

    Major bleeding event (BARC type 2-5).

  7. Stroke.

    Time frame: 12 month

    Stroke.

  8. Procedural success.

    Time frame: 12 month

    Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).

  9. Rate of patients with DAPT.

    Time frame: 1 month

    Rate of patients with DAPT.

  10. Rate of patients with DAPT.

    Time frame: From 1 to 3 months

    Rate of patients with DAPT.

  11. Rate of patients with DAPT.

    Time frame: From 3 to 6 months

    Rate of patients with DAPT.

  12. Rate of patients with DAPT.

    Time frame: From 6 to 12 months

    Rate of patients with DAPT.

  13. Collection of imaging data by Optical coherence tomography (OCT).

    Time frame: 12 month

    Collection of imaging data by OCT.

  14. Collection of imaging data by Intravascular Ultrasound (IVUS).

    Time frame: 12 month

    Collection of imaging data by IVUS.

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents". Sierra 75 Study

Acronym: SIERRA 75

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2018
Registry last updated
Aug 29, 2025

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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