Clinical trial NCT04475536: A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
Official title: A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Coronary Artery Disease
Keywords: Complex Lesions
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 501
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 de novo native and complex coronary artery lesions, candidate to undergo revascularisation with a coronary device.

Brief summary: This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.

Detailed description: This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years.
* With indication of percutaneous revascularization.
* Complex coronary lesion defined as:

  * Left main lesion AND/OR
  * Lesion located at a major bifurcation (side branch \>2mm) AND/OR
  * Lesion located in a small vessel (\<2.5 mm reference diameter by visual estimation) AND/OR
  * Lesion length \> 35 mm
* Informed consent signed.

Exclusion Criteria:

* Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention).
* Life expectancy of the patient under 1 year.
* Patients included in other studies or clinical trials.
* Clinical decision that excludes the use of drug-eluting stents.
* Confirmed allergy to aspirin and / or thienopyridines.

Primary outcomes:
measure: Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
timeFrame: 12 months
measure: Efficacy.The incidence of clinically driven target lesion revascularization.
timeFrame: 12 months
Secondary outcomes:
measure: All death.
timeFrame: 12 months
measure: Cardiac death.
timeFrame: 12 months
measure: Target Vessel revascularization.
timeFrame: 12 months
measure: Target lesion revascularization.
timeFrame: 12 months
measure: Stent thrombosis (ARC definite/probable).
timeFrame: 12 months
measure: Major bleeding event (BARC type 2-5).
timeFrame: 12 months
measure: Stroke.
timeFrame: 12 months
measure: Procedural success.
timeFrame: 12 months
measure: Rate of patients with DAPT
timeFrame: From 1 to 6 months
measure: Rate of patients with DAPT
timeFrame: From 6 to 12 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: LA Coruña
city: Albacete
country: Spain
facility: Hospital General Universitario
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Huelva
country: Spain
facility: Hospital General Juan Ramon Jimenez
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
city: León
country: Spain
facility: Hospital Universitario de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Agusti
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Murcia
country: Spain
facility: Hospital Clinico Universitario Virgen Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdcilla
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
References:
citation: Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, Carrie D, Ando K, Merkely B, Kornowski R, Eltchaninoff H, James S, Wijns W; CENTURY II Investigators. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial. Eur Heart J. 2014 Aug 7;35(30):2021-31. doi: 10.1093/eurheartj/ehu210. Epub 2014 May 19.
citation: Orvin K, Carrie D, Richardt G, Desmet W, Assali A, Werner G, Ikari Y, Fujii K, Goicolea J, Dangoisse V, Manari A, Saito S, Wijns W, Kornowski R. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial. Catheter Cardiovasc Interv. 2016 May;87(6):1092-100. doi: 10.1002/ccd.26150. Epub 2015 Aug 13.
citation: Lesiak M, Araszkiewicz A, Grajek S, Colombo A, Lalmand J, Carstensen S, Namiki A, Tobaru T, Merkely B, Moreno R, Barbato E, Wijns W, Saito S. Long Coronary Lesions Treated With Thin Strut Bioresorbable Polymer Drug Eluting Stent: Experience From Multicentre Randomized CENTURY II Study. J Interv Cardiol. 2016 Feb;29(1):47-56. doi: 10.1111/joic.12262.
citation: Derimay F, Souteyrand G, Motreff P, Rioufol G, Finet G. Influence of platform design of six different drug-eluting stents in provisional coronary bifurcation stenting by rePOT sequence: a comparative bench analysis. EuroIntervention. 2017 Oct 13;13(9):e1092-e1095. doi: 10.4244/EIJ-D-16-00863.
citation: Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.