Ischemic Heart DiseaseTANSEINCT04475536
A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by Fundación EPIC at 17 sites in Spain.
Trial summary
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Disease
- What is being tested?
- TANSEI stent
- Type of treatment
- Medical device
- How many people
- 501 participants
- Where
- 17 sitesSpain
- Study dates
- 21 Aug 2020to 1 Feb 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with de novo native and complex coronary artery lesions, candidate to undergo revascularisation with a coronary device.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Hospital Universitario de A Coruña
A Coruña, 15006
Hospital General Universitario
Albacete, 02006
Hospital Del Mar
Barcelona, 08003
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario de Cabueñes
Gijón, 33394
Hospital General Juan Ramon Jimenez
Huelva, 21005
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010
Hospital Universitario de León
León, 24001
Hospital Universitario Lucus Agusti
Lugo, 27003
Hospital Universitario Puerta de Hierro
Majadahonda, 28222
Hospital Universitario Virgen de La Victoria
Málaga, 29010
Hospital Clinico Universitario Virgen Arrixaca
Murcia, 30120
Hospital Universitario Marques de Valdcilla
Santander, 39008
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, LA Coruña, 15706
Hospital Clinico Universitario de Valencia
Valencia, 46010
About this study
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.
Read the detailed description
This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Being tested
- TANSEI stent
- Keywords
- Complex Lesions
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TANSEI stentDevice
stenting with the TANSEI sirolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (CAD) | Not described Receives: Device: TANSEI stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
Measured: 12 months
Efficacy.The incidence of clinically driven target lesion revascularization.
The incidence of clinically driven target lesion revascularization (TLR).
Measured: 12 months
Secondary outcomes (10)
All death.
All death.
Measured: 12 months
Cardiac death.
Cardiac death.
Measured: 12 months
Target Vessel revascularization.
Target Vessel revascularization.
Measured: 12 months
Target lesion revascularization.
Target lesion revascularization.
Measured: 12 months
Stent thrombosis (ARC definite/probable).
Stent thrombosis (ARC definite/probable).
Measured: 12 months
Major bleeding event (BARC type 2-5).
Major bleeding event (BARC type 2-5).
Measured: 12 months
Stroke.
Stroke.
Measured: 12 months
Procedural success.
Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).
Measured: 12 months
Rate of patients with DAPT
Rate of patients with DAPT
Measured: From 1 to 6 months
Rate of patients with DAPT
Rate of patients with DAPT
Measured: From 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start21 Aug 2020
- Primary completion1 May 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475536
- Sponsor's protocol ID
- EPIC08-TANSEI
- Acronym
- TANSEI
- Status last verified
- Feb 2025
- First submitted
- 16 Jul 2020
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24847155Orvin 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.
PubMed 26268482Lesiak 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.
PubMed 26864951Derimay 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.
PubMed 28485275Chevalier 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.
PubMed 29246909
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
- ClinicalTrials.gov ID
- NCT04475536
- Acronym / sponsor ID
- TANSEI / EPIC08-TANSEI
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Keywords
- Complex Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) | – | Device: TANSEI stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with de novo native and complex coronary artery lesions, candidate to undergo revascularisation with a coronary device.
Key inclusion criteria (8 listed)
- Age> 18 years.
- With indication of percutaneous revascularization.
- Complex coronary lesion defined as:
- Informed consent signed.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TANSEI stentstenting with the TANSEI sirolimus-eluting stent | Device | Coronary Artery Disease (CAD) |
Primary outcome
Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
Time frame: 12 months
The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
Efficacy.The incidence of clinically driven target lesion revascularization.
Time frame: 12 months
The incidence of clinically driven target lesion revascularization (TLR).
10 secondary outcomes
All death.
Time frame: 12 months
Cardiac death.
Time frame: 12 months
Target Vessel revascularization.
Time frame: 12 months
Target lesion revascularization.
Time frame: 12 months
Stent thrombosis (ARC definite/probable).
Time frame: 12 months
Major bleeding event (BARC type 2-5).
Time frame: 12 months
Stroke.
Time frame: 12 months
Procedural success.
Time frame: 12 months
Rate of patients with DAPT
Time frame: From 1 to 6 months
Rate of patients with DAPT
Time frame: From 6 to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 24847155Saito 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.
- Background: PubMed 26268482Orvin 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.
- Background: PubMed 26864951Lesiak 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.
- Background: PubMed 28485275Derimay 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.
- Background: PubMed 29246909Chevalier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by Fundación EPIC at 17 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475536, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.