Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

Coronary Artery Disease Clinical Trial

— VELAZQUEZ  

Official title:

Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04899141
• Other study ID #: EPIC26-VELAZQUEZ
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

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