Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

NCT04899141 | Active Not Recruiting DMC

• 1 other identifier: EPIC26-VELAZQUEZ
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 20

Brief Summary

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

Conditions

Coronary Artery Disease; Ischemic Heart Disease

Keywords

Percutaneous Coronary Intervention; Drug Eluting Stent

Outcome Measures

Primary Outcomes (10)

• Target Lesion Failure (TLF)

  Rate of target lesion failure

  2 years

• Target Lesion Failure (TLF)

  Rate of target lesion failure

  5 years

• Death

  Death

  2 years

• Death

  Death

  5 years

• Target vessel myocardial infarction

  Target vessel myocardial infarction

  2 years

• Target vessel myocardial infarction

  Target vessel myocardial infarction

  5 years

• Target lesion revascularization (TLR)

  Target lesion revascularization (TLR)

  2 years

• Target lesion revascularization (TLR)

  Target lesion revascularization (TLR)

  5 years

• Cardiovascular Death

  Cardiovascular Death

  2 years

• Cardiovascular Death

  Cardiovascular Death

  5 years

Secondary Outcomes (12)

• Stent thrombosis

  2 years

• Stent thrombosis

  5 years

• Target Vessel Failure (TVF)

  2 years

• Target Vessel Failure (TVF)

  5 years

• Major Adverse Cardiovascular Event (MACE)

  2 years

Study Arms (1)

Coronary Artery Disease

Device: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention DEVICE

stenting with the ihtDEStiny® sirolimus eluting stent

Coronary Artery Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with all inclusion criteria

You may qualify if:

• ≥18 years old
• PCI and stent implantation indication according to ESC Myocardial Revascularization Guidelines
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (20)

Centro Hospitalar Universitario Do Algarbe

Faro, 8000-386, Portugal

Location

Hospital Universitario Regional de Malaga Carlos Haya

Málaga, Malaga, 29010, Spain

Location

Hospital Universitario de Cruces

Barakaldo, 48903, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, 20014, Spain

Location

Hospital General Universitario de Elche

Elche, 03203, Spain

Location

Hospital de Galdakao

Galdakao, 48960, Spain

Location

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital Universitario Lucus Agusti

Lugo, 27003, Spain

Location

Hospital Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario de Araba

Vitoria-Gasteiz, 01009, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (5)

• 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.

  PMID: 33060037 BACKGROUND

• 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.

  PMID: 33386256 BACKGROUND

• 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.

  PMID: 31422087 BACKGROUND

• 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.

  PMID: 28279314 BACKGROUND

• 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.

  PMID: 30292330 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: October 29, 2021
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

PT (1); ES (19)