Sign in

NCT04475536Completed

A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.

Source: ClinicalTrials.gov · Last updated 26 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
501 (actual)
First submitted
16 Jul 2020
Start date
21 Aug 2020
Primary completion date
1 May 2023
Lead sponsor
Fundación EPIC
NCT number
NCT04475536

What you commit to

  • Study type: Observational
  • Participants enrolled: 501
  • From 21 Aug 2020 to the primary completion date, 1 May 2023
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Clinical decision that excludes the use of drug-eluting stents.

Other illness

  • Confirmed allergy to aspirin and / or thienopyridines.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario de A Coruna
Coordinator of this site? Confirm its status
A CoruñaSpainUnknown status
Hospital General Universitario
Coordinator of this site? Confirm its status
AlbaceteSpainUnknown status
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital General Universitario de Ciudad Real
Coordinator of this site? Confirm its status
Ciudad RealSpainUnknown status
Hospital Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainUnknown status
Hospital Universitario de Cabueñes
Coordinator of this site? Confirm its status
GijónSpainUnknown status
Hospital General Juan Ramon Jimenez
Coordinator of this site? Confirm its status
HuelvaSpainUnknown status
Hospital Universitario de Gran Canaria Dr Negrín
Coordinator of this site? Confirm its status
Las Palmas de Gran CanariaSpainUnknown status
Hospital Universitario De Leon
Coordinator of this site? Confirm its status
LeónSpainUnknown status
Hospital Universitario Lucus Agusti
Coordinator of this site? Confirm its status
LugoSpainUnknown status
Hospital Universitario Puerta de Hierro
Coordinator of this site? Confirm its status
MajadahondaSpainUnknown status
Hospital Universitario Virgen de la Victoria
Coordinator of this site? Confirm its status
MálagaSpainUnknown status
Hospital Clinico Universitario Virgen Arrixaca
Coordinator of this site? Confirm its status
MurciaSpainUnknown status
Hospital Universitario Marques de Valdcilla
Coordinator of this site? Confirm its status
SantanderSpainUnknown status
Hospital Clínico Universitario de Santiago de Compostela
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainUnknown status
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.