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NCT03567733 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— SIERRA 75  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03567733
Other study ID # SIERRA 75 EPIC-05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 18, 2018
Est. completion date October 21, 2020

Study information
Verified date October 2020
Source Fundación EPIC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date October 21, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• XIENCE Sierra
Percutaneous coronary intervention

Locations
Country Name City State
Portugal Hospital Garcia de Orta Almada
Portugal Centro Hospitalar Lisboa Occidental. Hospital de Santa Cruz Carnaxide
Portugal Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE Espinho
Portugal Hospital do Espírito Santo de Évora Évora
Portugal Hospital Do Divino Espirito Santo Ponta Delgada
Portugal Hospital Do Divino Espirito Santo De Ponta Delgada Ponta Delgada
Portugal Centro Hospitalar de Setubal, EPE - Hospital Sao Bernardo Setubal
Spain Hospital General Universitario de Albacete Albacete
Spain Hospital Universitario San Juan de Alicante Alicante
Spain Hospital Infanta Cristina Badajoz
Spain Hospital Universitari Germans Trias I Pujol de Badalona Badalona Barcelona
Spain Hospital Universitario de Cruces Barakaldo
Spain Hospital Universitari Vall D'Hebron Barcelona
Spain Hospital Universitario de Burgos Burgos
Spain Hospital Puerta Del Mar Cádiz
Spain Hospital Universitario Vinalopo Elche Alicante
Spain Hospital Galdakao-Usansolo Galdakao
Spain Hospital de Cabueñes Gijón
Spain Hospital Universitario Virgen de Las Nieves Granada
Spain Hospital General Juan Ramón Jiménez Huelva
Spain Complejo Hospitalario de Jaén Jaen
Spain Hospital de León León
Spain Hospital Universitario Lucus Augusti Lugo
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Majadahonda
Spain Complejo Hospitalario Regional de Málaga Malaga
Spain Hospital de Mérida Mérida Badajoz
Spain Hospital Clinico Universitario Virgen de La Arrixaca Murcia
Spain Hospital Universitari Son Espases Palma De Mallorca Mallorca
Spain Clinica Universidad de Navarra Pamplona
Spain Hospital de Puerto Real Puerto Real Cádiz
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Nuestra Señora de la Candelaria Santa Cruz De Tenerife
Spain Hospital Universitario de Canarias Santa Cruz De Tenerife
Spain Hospital Universitario Marqués de Valdecilla Santander
Spain Hospital Clínico Universitario de Santiago Santiago De Compostela
Spain Hospital Virgen de La Salud Toledo
Spain Hospital de Torrevieja Torrevieja Alicante
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital Universitari I Politècnic La Fe Valencia
Spain Hospital Universitario Álvaro Cunqueiro Vigo
Spain Hospital Universitario de Araba Vitoria-Gasteiz Álava
Spain Hospital Clínico Universitario Lozano Blesa Zaragoza
Spain Hospital Universitario Miguel Servet Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Fundación EPIC

Countries where clinical trial is conducted

Portugal,  Spain, 

References & Publications (7)

Costa F, van Klaveren D, James S, Heg D, Räber 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 — View Citation

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 — View Citation

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. — View Citation

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 C — View Citation

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: — View Citation

Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrié D, Naber C, Lipiecki J, Richardt G, Iñiguez 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 — View Citation

Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Jüni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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).
.		 12 month
Primary Efficacy.The incidence of clinically driven target lesion revascularization (TLR). The incidence of clinically driven target lesion revascularization (TLR). 12 month
Secondary All death. All death.
Systemic embolism, Major bleeding event (BARC = 2)		 12 month
Secondary Cardiac death. Cardiac death. 12 month
Secondary Target Vessel revascularization. Target Vessel revascularization. 12 month
Secondary Target lesion revascularization. Target lesion revascularization. 12 month
Secondary Stent thrombosis (ARC definite/probable). Stent thrombosis (ARC definite/probable). 12 month
Secondary Major bleeding event (BARC type 2-5). Major bleeding event (BARC type 2-5). 12 month
Secondary Stroke. Stroke. 12 month
Secondary Procedural success. Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment). 12 month
Secondary Rate of patients with DAPT. Rate of patients with DAPT. 1 month
Secondary Rate of patients with DAPT. Rate of patients with DAPT. From 1 to 3 months
Secondary Rate of patients with DAPT. Rate of patients with DAPT. From 3 to 6 months
Secondary Rate of patients with DAPT. Rate of patients with DAPT. From 6 to 12 months
Secondary Collection of imaging data by Optical coherence tomography (OCT). Collection of imaging data by OCT. 12 month
Secondary Collection of imaging data by Intravascular Ultrasound (IVUS). Collection of imaging data by IVUS. 12 month
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