Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice (VELAZQUEZ)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Ischemic Heart Disease
• Intervention / Treatment: Device: Percutaneous Coronary Intervention

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 6 0034987876135; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: JOSE ANTONIO LINARES VICENTE, MD,PhD; Email: jalinares@asociacionepic.org

Study Locations

• Portugal
  • Faro, Portugal, 8000-386
    • Centro Hospitalar Universitario Do Algarbe
• Spain
  • Barakaldo, Spain, 48903
    • Hospital Universitario de Cruces
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Ciudad Real, Spain, 13005
    • Hospital General Universitario De Ciudad Real
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcántara
  • Donostia, Spain, 20014
    • Hospital Universitario Donostia
  • Elche, Spain, 03203
    • Hospital General Universitario de Elche
  • Galdakao, Spain, 48960
    • Hospital de Galdakao
  • Gasteiz / Vitoria, Spain, 01009
    • Hospital Universitario de Araba
  • Hospitalet de Llobregat, Spain, 08907
    • Hospital Universitari de Bellvitge
  • Huelva, Spain, 21005
    • Hospital Universitario Juan Ramon Jimenez
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova de Lleida
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Agusti
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen Arrixaca
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Santiago De Compostela, Spain, 15706
    • Hospital Clinico Universitario Santiago de Compostela
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • Hospital Universitario Regional de Malaga Carlos Haya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with all inclusion criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease	Device: Percutaneous Coronary Intervention; stenting with the ihtDEStiny® sirolimus eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	Rate of target lesion failure	2 years
Death	Death	2 years
Target vessel myocardial infarction	Target vessel myocardial infarction	2 years
Target lesion revascularization (TLR)	Target lesion revascularization (TLR)	2 years
Cardiovascular Death	Cardiovascular Death	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Drug Eluting Stent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: EPIC26-VELAZQUEZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No