Clinical trial NCT04899141: Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice
Official title: Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: Percutaneous Coronary Intervention
Drug Eluting Stent
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with all inclusion criteria

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 2 years
measure: Death
timeFrame: 2 years
measure: Target vessel myocardial infarction
timeFrame: 2 years
measure: Target lesion revascularization (TLR)
timeFrame: 2 years
measure: Cardiovascular Death
timeFrame: 2 years
Secondary outcomes:
measure: Stent thrombosis
timeFrame: 2 years
measure: Target Vessel Failure (TVF)
timeFrame: 2 years
measure: Major Adverse Cardiovascular Event (MACE)
timeFrame: 2 years
measure: Patient Oriented Composite Event
timeFrame: 2 years
measure: Severe BARC Bleeding
timeFrame: 2 years
measure: Device success
timeFrame: During procedure
measure: Procedural success
timeFrame: 3 days
Other outcomes:
Locations:
city: Faro
country: Portugal
facility: Centro Hospitalar Universitario Do Algarbe
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Malaga Carlos Haya
state: Malaga
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Galdakao
country: Spain
facility: Hospital de Galdakao
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario de Araba
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Agusti
city: Murcia
country: Spain
facility: Hospital Universitario Virgen Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
Study officials:
References:
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.
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.
citation: 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.
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.
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.