TANSEI: A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
Study Details
Study Description
Brief Summary
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Coronary Artery Disease (CAD)
|
Device: TANSEI stent
stenting with the TANSEI sirolimus-eluting stent
|
Outcome Measures
Primary Outcome Measures
- Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). [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. [12 months]
The incidence of clinically driven target lesion revascularization (TLR).
Secondary Outcome Measures
- All death. [12 months]
All death.
- Cardiac death. [12 months]
Cardiac death.
- Target Vessel revascularization. [12 months]
Target Vessel revascularization.
- Target lesion revascularization. [12 months]
Target lesion revascularization.
- Stent thrombosis (ARC definite/probable). [12 months]
Stent thrombosis (ARC definite/probable).
- Major bleeding event (BARC type 2-5). [12 months]
Major bleeding event (BARC type 2-5).
- Stroke. [12 months]
Stroke.
- Procedural success. [12 months]
Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment).
- Rate of patients with DAPT [From 1 to 6 months]
Rate of patients with DAPT
- Rate of patients with DAPT [From 6 to 12 months]
Rate of patients with DAPT
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinico Universitario de Santiago de Compostela | Santiago De Compostela | LA Coruña | Spain | 15706 |
| 2 | Hospital General Universitario | Albacete | Spain | 02006 | |
| 3 | Hospital Del Mar | Barcelona | Spain | 08003 | |
| 4 | Hospital Universitari Vall D'Hebron | Barcelona | Spain | 08035 | |
| 5 | Hospital General Universitario de Ciudad Real | Ciudad Real | Spain | 13005 | |
| 6 | Hospital Universitario de A Coruña | Coruña | Spain | 15006 | |
| 7 | Hospital Universitario Reina Sofia | Córdoba | Spain | 14004 | |
| 8 | Hospital Universitario de Cabueñes | Gijón | Spain | 33394 | |
| 9 | Hospital General Juan Ramon Jimenez | Huelva | Spain | 21005 | |
| 10 | Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas De Gran Canaria | Spain | 35010 | |
| 11 | Hospital Universitario de León | León | Spain | 24001 | |
| 12 | Hospital Universitario Lucus Agusti | Lugo | Spain | 27003 | |
| 13 | Hospital Universitario Puerta de Hierro | Majadahonda | Spain | 28222 | |
| 14 | Hospital Clinico Universitario Virgen Arrixaca | Murcia | Spain | 30120 | |
| 15 | Hospital Universitario Virgen de La Victoria | Málaga | Spain | 29010 | |
| 16 | Hospital Universitario Marques de Valdcilla | Santander | Spain | 39008 | |
| 17 | Hospital Clinico Universitario de Valencia | Valencia | Spain | 46010 |
Sponsors and Collaborators
- Fundación EPIC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Chevalier B, Smits PC, Carrié D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamié 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). pii: e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.
- 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.
- 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.
- 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.
- 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.
- EPIC08-TANSEI