Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice
NCT ID: NCT04899141
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
400 participants
OBSERVATIONAL
2021-10-29
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Coronary Artery Disease
Percutaneous Coronary Intervention
stenting with the ihtDEStiny® sirolimus eluting stent
Interventions
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Percutaneous Coronary Intervention
stenting with the ihtDEStiny® sirolimus eluting stent
Eligibility Criteria
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Inclusion Criteria
* PCI and stent implantation indication according to ESC Myocardial Revascularization Guidelines
* 1 or more stenosis at native coronary anatomy, in a 2-4mm vessel size, where 1 or more ihtDEStiny® drug eluting stent were implanted (or attempted to be implanted).
* Informed consent signed after PCI
Exclusion Criteria
* Pregnancy
* Other DES implantation during index PCI, or 30 days before of after index PCI
* PCI at surgical grafts
* PCI for in-stent restenosis
* Killip class 3-4 Acute Coronary Syndromes (ACS)
* High bleeding risk with dual antiplatelet intolerance for at least 3 months (or 6 months for ACS PCI)
* Allergy or hypersensitivity to sirolimus
* Patients requiring surgery (cardiac or non-cardiac) in the next 3 months after index PCI
* Patients with life expectancy \<2 years
* Patients included in other trials or clinical studies
18 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Centro Hospitalar Universitario Do Algarbe
Faro, , Portugal
Hospital Universitario Regional de Malaga Carlos Haya
Málaga, Malaga, Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario Donostia
Donostia / San Sebastian, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital de Galdakao
Galdakao, , Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, , Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, , Spain
Hospital Universitario Lucus Agusti
Lugo, , Spain
Hospital Universitario Virgen de La Victoria
Málaga, , Spain
Hospital Universitario Virgen Arrixaca
Murcia, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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References
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de la Torre Hernandez JM, Ocaranza Sanchez R, Santas Alvarez M, Pinar Bermudez E, Hurtado Martinez JA, Garcia Del Blanco B, Otaegui I, Fernandez Nofrerias E, Carrillo Suarez X, Sainz Laso F, Casanova Sandoval JM, Rivera Aguilar PK, Cid B, Trillo R, Lozano Ruiz-Poveda F, Peral Disdier V, Telleria M, Torres A, Sanchis J, Oliva X, Freixa X, Sadaba Sagredo M, Moreu J, Hernandez F. Comparison of One-Year Outcomes Between the ihtDEStiny BD Stent and the Durable-Polymer Everolimus- and Zotarolimus-Eluting Stents: A Propensity-Score-Matched Analysis. Cardiovasc Revasc Med. 2021 Oct;31:1-6. doi: 10.1016/j.carrev.2020.09.046. Epub 2020 Oct 3.
de la Torre Hernandez JM, Otaegui I, Subinas A, Gomez-Menchero A, Moreno R, Rondan J, Munoz-Garcia E, Sainz-Laso F, Garcia Del Blanco B, Rumoroso JR, Diaz JF, Berenguer A, Gomez-Lara J, Zueco J. First-in-Man Evaluation of a Sirolimus-Eluting Stent With Abluminal Fluoropolymeric/Triflusal Coating With Ultrathin Struts by OCT at 9 Months' Follow-Up: The PROMETHEUS Study. Cardiovasc Revasc Med. 2021 Nov;32:18-24. doi: 10.1016/j.carrev.2020.12.025. Epub 2020 Dec 29.
Buiten RA, Ploumen EH, Zocca P, Doggen CJM, Danse PW, Schotborgh CE, Scholte M, van Houwelingen KG, Stoel MG, Hartmann M, Tjon Joe Gin RM, Somi S, Linssen GCM, Kok MM, von Birgelen C. Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1650-1660. doi: 10.1016/j.jcin.2019.04.054. Epub 2019 Aug 14.
El-Hayek G, Bangalore S, Casso Dominguez A, Devireddy C, Jaber W, Kumar G, Mavromatis K, Tamis-Holland J, Samady H. Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents. JACC Cardiovasc Interv. 2017 Mar 13;10(5):462-473. doi: 10.1016/j.jcin.2016.12.002.
Iantorno M, Lipinski MJ, Garcia-Garcia HM, Forrestal BJ, Rogers T, Gajanana D, Buchanan KD, Torguson R, Weintraub WS, Waksman R. Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery. Am J Cardiol. 2018 Nov 15;122(10):1652-1660. doi: 10.1016/j.amjcard.2018.07.040. Epub 2018 Sep 8.
Other Identifiers
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EPIC26-VELAZQUEZ
Identifier Type: -
Identifier Source: org_study_id
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