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
- Diseases
- Coronary artery disease
- 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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de A Coruna Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital General Universitario Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| Hospital General Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital Universitario de Gran Canaria Dr Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital Universitario Lucus Agusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Clinico Universitario Virgen Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Universitario Marques de Valdcilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clínico Universitario de Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.