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

August 23, 2025 updated by: Fundación EPIC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

1000

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

  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta
      • Carnaxide, Portugal, 2790-134
        • Centro Hospitalar Lisboa Occidental. Hospital de Santa Cruz
      • Espinho, Portugal, 4401-860
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
      • Evora, Portugal, 7000
        • Hospital do Espírito Santo de Évora
      • Ponta Delgada, Portugal, 9500-370
        • Hospital Do Divino Espirito Santo
      • Ponta Delgada, Portugal, 9500-370
        • Hospital Do Divino Espirito Santo De Ponta Delgada
      • Setúbal, Portugal, 2910-446
        • Centro Hospitalar de Setubal, EPE - Hospital Sao Bernardo
  • Spain
      • Albacete, Spain, 02006
        • Hospital General Universitario de Albacete
      • Alicante, Spain, 03550
        • Hospital Universitario San Juan de Alicante
      • Badajoz, Spain, 06080
        • Hospital Infanta Cristina
      • Barakaldo, Spain, 48903
        • Hospital Universitario de Cruces
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Cadiz, Spain, 11009
        • Hospital Puerta del Mar
      • Galdakao, Spain, 48960
        • Hospital Galdakao-Usansolo
      • Gijón, Spain, 33394
        • Hospital de Cabuenes
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Huelva, Spain, 21005
        • Hospital General Juan Ramon Jimenez
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaén
      • León, Spain, 24080
        • Hospital de Leon
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Murcia, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Málaga, Spain, 29010
        • Complejo Hospitalario Regional de Málaga
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Nuestra Señora de La Candelaria
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Vigo, Spain, 36312
        • Hospital Universitario Alvaro Cunqueiro
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Alicante
      • Elche, Alicante, Spain, 03293
        • Hospital Universitario Vinalopo
      • Torrevieja, Alicante, Spain, 03186
        • Hospital de Torrevieja
    • Badajoz
      • Mérida, Badajoz, Spain, 06800
        • Hospital de Merida
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias I Pujol de Badalona
    • Cádiz
      • Puerto Real, Cádiz, Spain, 11510
        • Hospital de Puerto Real
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07120
        • Hospital Universitari Son Espases
    • Álava
      • Vitoria-Gasteiz, Álava, Spain, 01009
        • Hospital Universitario de Araba

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

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients older than 75 years with de novo native coronary artery lesions, candidate to undergo revascularisation with a coronary device.

Description

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.

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: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Artery Disease
Drug- eluting Stent
Device: XIENCE Sierra
Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

.
12 month
Efficacy.The incidence of clinically driven target lesion revascularization (TLR).
Time Frame: 12 month
The incidence of clinically driven target lesion revascularization (TLR).
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All death.
Time Frame: 12 month

All death.

Systemic embolism, Major bleeding event (BARC ≥ 2)
12 month
Cardiac death.
Time Frame: 12 month
Cardiac death.
12 month
Target Vessel revascularization.
Time Frame: 12 month
Target Vessel revascularization.
12 month
Target lesion revascularization.
Time Frame: 12 month
Target lesion revascularization.
12 month
Stent thrombosis (ARC definite/probable).
Time Frame: 12 month
Stent thrombosis (ARC definite/probable).
12 month
Major bleeding event (BARC type 2-5).
Time Frame: 12 month
Major bleeding event (BARC type 2-5).
12 month
Stroke.
Time Frame: 12 month
Stroke.
12 month
Procedural success.
Time Frame: 12 month
Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).
12 month
Rate of patients with DAPT.
Time Frame: 1 month
Rate of patients with DAPT.
1 month
Rate of patients with DAPT.
Time Frame: From 1 to 3 months
Rate of patients with DAPT.
From 1 to 3 months
Rate of patients with DAPT.
Time Frame: From 3 to 6 months
Rate of patients with DAPT.
From 3 to 6 months
Rate of patients with DAPT.
Time Frame: From 6 to 12 months
Rate of patients with DAPT.
From 6 to 12 months
Collection of imaging data by Optical coherence tomography (OCT).
Time Frame: 12 month
Collection of imaging data by OCT.
12 month
Collection of imaging data by Intravascular Ultrasound (IVUS).
Time Frame: 12 month
Collection of imaging data by IVUS.
12 month

Collaborators and Investigators

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

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 18, 2018

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

October 21, 2020

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 23, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIERRA 75 EPIC-05

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

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.

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