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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04899141
Other study ID # EPIC26-VELAZQUEZ
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 29, 2021
Est. completion date April 1, 2025

Study information

Verified date January 2024
Source Fundación EPIC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.


Description:

Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent use in real-world percutaneous coronary intervention


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date April 1, 2025
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - =18 years old - 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: - Patient refusal to participate in the study - 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

Study Design


Intervention

Device:
Percutaneous Coronary Intervention
stenting with the ihtDEStiny® sirolimus eluting stent

Locations

Country Name City State
Portugal Centro Hospitalar Universitario Do Algarbe Faro
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
Spain Hospital General Universitario de Elche Elche
Spain Hospital de Galdakao Galdakao
Spain Hospital Universitario de Araba Gasteiz / Vitoria
Spain Hospital Universitari de Bellvitge Hospitalet de Llobregat
Spain Hospital Universitario Juan Ramon Jimenez Huelva
Spain Hospital Universitari Arnau de Vilanova de Lleida Lleida
Spain Hospital Universitario Lucus Agusti Lugo
Spain Hospital Universitario Regional de Malaga Carlos Haya Málaga Malaga
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 Clinico Universitario Lozano Blesa Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Fundación EPIC

Countries where clinical trial is conducted

Portugal,  Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Target Lesion Failure (TLF) Rate of target lesion failure 2 years
Primary Death Death 2 years
Primary Target vessel myocardial infarction Target vessel myocardial infarction 2 years
Primary Target lesion revascularization (TLR) Target lesion revascularization (TLR) 2 years
Primary Cardiovascular Death Cardiovascular Death 2 years
Secondary Stent thrombosis Stent thrombosis 2 years
Secondary Target Vessel Failure (TVF) Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR) 2 years
Secondary Major Adverse Cardiovascular Event (MACE) Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke 2 years
Secondary Patient Oriented Composite Event Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization 2 years
Secondary Severe BARC Bleeding BARC Bleeding =3 2 years
Secondary Device success residual coronary stenosis<50%, normal coronary flow and absence of coronary dissection =C During procedure
Secondary Procedural success Device success and absence of PCI complication (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 days 3 days
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