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Ischemic Heart DiseaseSIERRA 75NCT03567733

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

An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by Fundación EPIC at 44 sites in 2 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 prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent. Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
XIENCE Sierra
Type of treatment
Medical device
How many people
1,000 participants
Where
44 sitesin 2 countries
Study dates
18 Jun 2018to 21 Oct 2020
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

Spain37 sites

  • Hospital General Universitario de Albacete

    Albacete, 02006

  • Hospital Universitario San Juan de Alicante

    Alicante, 03550

  • Hospital Infanta Cristina

    Badajoz, 06080

  • Hospital Universitari Germans Trias I Pujol de Badalona

    Badalona, Barcelona, 08916

  • Hospital Universitario de Cruces

    Barakaldo, 48903

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital Puerta Del Mar

    Cadiz, 11009

  • Hospital Universitario Vinalopo

    Elche, Alicante, 03293

  • Hospital Galdakao-Usansolo

    Galdakao, 48960

  • Hospital de Cabueñes

    Gijón, 33394

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014

  • Hospital General Juan Ramón Jiménez

    Huelva, 21005

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital de León

    León, 24080

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Complejo Hospitalario Regional de Málaga

    Málaga, 29010

  • Hospital de Mérida

    Mérida, Badajoz, 06800

  • Hospital Clinico Universitario Virgen de La Arrixaca

    Murcia, 30120

  • Hospital Universitari Son Espases

    Palma de Mallorca, Mallorca, 07120

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital de Puerto Real

    Puerto Real, Cádiz, 11510

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Nuestra Señora de la Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen de La Salud

    Toledo, 45004

  • Hospital de Torrevieja

    Torrevieja, Alicante, 03186

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari I Politècnic La Fe

    Valencia, 46026

  • Hospital Universitario Álvaro Cunqueiro

    Vigo, 36312

  • Hospital Universitario de Araba

    Vitoria-Gasteiz, Álava, 01009

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Portugal7 sites

  • Hospital Garcia de Orta

    Almada, 2805-267

  • Centro Hospitalar Lisboa Occidental. Hospital de Santa Cruz

    Carnaxide, 2790-134

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

    Espinho, 4401-860

  • Hospital do Espírito Santo de Évora

    Evora, 7000

  • Hospital Do Divino Espirito Santo De Ponta Delgada

    Ponta Delgada, 9500-370

  • Hospital Do Divino Espirito Santo

    Ponta Delgada, 9500-370

  • Centro Hospitalar de Setubal, EPE - Hospital Sao Bernardo

    Setúbal, 2910-446

Other trials in Portugal

About this study

Official title: 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.

Read the 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).

Being tested
XIENCE Sierra
Keywords
Dual antiplatelet treatment, Elderly patients
Medical subject headings
Myocardial Ischemia, Coronary Artery Disease

What participants receive

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

  • XIENCE SierraDevice

    Percutaneous coronary intervention

Study groups in NCT03567733
Study groupRoleWhat they receive
Coronary Artery DiseaseDrug- eluting Stent
Receives: Device: XIENCE Sierra

What is being measured

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

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

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

    .

    Measured: 12 month

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

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

    Measured: 12 month

Secondary outcomes (14)

  1. All death.

    All death.

    Systemic embolism, Major bleeding event (BARC ≥ 2)

    Measured: 12 month

  2. Cardiac death.

    Cardiac death.

    Measured: 12 month

  3. Target Vessel revascularization.

    Target Vessel revascularization.

    Measured: 12 month

  4. Target lesion revascularization.

    Target lesion revascularization.

    Measured: 12 month

  5. Stent thrombosis (ARC definite/probable).

    Stent thrombosis (ARC definite/probable).

    Measured: 12 month

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

    Major bleeding event (BARC type 2-5).

    Measured: 12 month

  7. Stroke.

    Stroke.

    Measured: 12 month

  8. Procedural success.

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

    Measured: 12 month

  9. Rate of patients with DAPT.

    Rate of patients with DAPT.

    Measured: 1 month

  10. Rate of patients with DAPT.

    Rate of patients with DAPT.

    Measured: From 1 to 3 months

  11. Rate of patients with DAPT.

    Rate of patients with DAPT.

    Measured: From 3 to 6 months

  12. Rate of patients with DAPT.

    Rate of patients with DAPT.

    Measured: From 6 to 12 months

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

    Collection of imaging data by OCT.

    Measured: 12 month

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

    Collection of imaging data by IVUS.

    Measured: 12 month

Timeline

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

  1. First posted26 Jun 2018
  2. Study start18 Jun 2018
  3. Primary completion1 Sep 2020
  4. Study completion21 Oct 2020

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
Case only
Time perspective
Prospective
Enrolment
1,000 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03567733
Sponsor's protocol ID
SIERRA 75 EPIC-05
Acronym
SIERRA 75
Status last verified
Aug 2025
First submitted
12 Jun 2018
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Costa F, van Klaveren D, James S, Heg D, Raber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017 Mar 11;389(10073):1025-1034. doi: 10.1016/S0140-6736(17)30397-5.

    PubMed 28290994

  • Valgimigli M, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2017 Aug 26

  • Kedhi E, Stone GW, Kereiakes DJ, Serruys PW, Parise H, Fahy M, Simonton CA, Sudhir K, Sood P, Smits PC. Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials. EuroIntervention. 2012 Sep;8(5):599-606. doi: 10.4244/EIJV8I5A92.

    PubMed 22995087

  • de Belder A, de la Torre Hernandez JM, Lopez-Palop R, O'Kane P, Hernandez Hernandez F, Strange J, Gimeno F, Cotton J, Diaz Fernandez JF, Carrillo Saez P, Thomas M, Pinar E, Curzen N, Baz JA, Cooter N, Lozano I, Skipper N, Robinson D, Hildick-Smith D; XIMA Investigators. A prospective randomized trial of everolimus-eluting stents versus bare-metal stents in octogenarians: the XIMA Trial (Xience or Vision Stents for the Management of Angina in the Elderly). J Am Coll Cardiol. 2014 Apr 15;63(14):1371-5. doi: 10.1016/j.jacc.2013.10.053. Epub 2013 Nov 21.

    PubMed 24216285

  • Gao L, Hu X, Liu YQ, Xue Q, Wang Y. Comparison of coronary DES and BMS in octogenarians: A systematic review and meta-analysis. J Geriatr Cardiol. 2013 Dec;10(4):336-43. doi: 10.3969/j.issn.1671-5411.2013.04.004.

    PubMed 24454326

  • Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.

    PubMed 26466021

  • Morice MC, Talwar S, Gaemperli O, Richardt G, Eberli F, Meredith I, Zaman A, Fajadet J, Copt S, Greene S, Urban P. Drug-coated versus bare-metal stents for elderly patients: A predefined sub-study of the LEADERS FREE trial. Int J Cardiol. 2017 Sep 15;243:110-115. doi: 10.1016/j.ijcard.2017.04.079. Epub 2017 Apr 25.

    PubMed 28579168

  • de la Torre Hernandez JM, Palop RL, Jimenez Mazuecos JM, Saez PC, Gutierez-Barrios A, Pinar E, Cid B, Fernandez L, Camarero TG, Urbano-Carrillo C, Oteo Dominguez JF, Jimenez Diaz VA, Gomez Menchero AE, Fernandez EG, Cordoba Soriano JG, Ocaranza R, Ucar EA, Roman KGS, Leal S, Caceres GM, Linares Vicente JA, Ferre GF, Carrillo X, Rama Merchan JC, Costa C, Sanchis J, Fernandes R, Rodrigues A, Vegas Valle JM, Pereira H, de Prado AP. Prospective application of a bleeding and ischemic risks-adjusted antithrombotic protocol in elderly patients revascularized with everolimus-eluting stents: EPIC05-Sierra75 study. J Geriatr Cardiol. 2022 May 28;19(5):354-366. doi: 10.11909/j.issn.1671-5411.2022.05.009.

    PubMed 35722037

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by Fundación EPIC at 44 sites in 2 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 4 inclusion and 6 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 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Spain, Portugal. 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?

Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). . (time frame: 12 month). The study lists 2 primary outcomes in all. 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 NCT03567733, which also lists 8 linked publications.

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 29 Aug 2025.

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