Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.
This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease (CAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TANSEI stent | Device | stenting with the TANSEI sirolimus-eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Efficacy.The incidence of clinically driven target lesion revascularization. | The incidence of clinically driven target lesion revascularization (TLR). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All death. | All death. | 12 months |
| Cardiac death. | Cardiac death. | 12 months |
Not provided
Inclusion Criteria:
Age> 18 years.
With indication of percutaneous revascularization.
Complex coronary lesion defined as:
Informed consent signed.
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with de novo native and complex coronary artery lesions, candidate to undergo revascularisation with a coronary device.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario de Santiago de Compostela | Santiago de Compostela | LA Coruña | 15706 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24847155 | Background | 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. | |
| 26268482 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Target Vessel revascularization. | Target Vessel revascularization. | 12 months |
| Target lesion revascularization. | Target lesion revascularization. | 12 months |
| Stent thrombosis (ARC definite/probable). | Stent thrombosis (ARC definite/probable). | 12 months |
| Major bleeding event (BARC type 2-5). | Major bleeding event (BARC type 2-5). | 12 months |
| Stroke. | Stroke. | 12 months |
| Procedural success. | Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment). | 12 months |
| Rate of patients with DAPT | 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 |
| Hospital Universitario de A Coruña |
| A Coruña |
| 15006 |
| Spain |
| Hospital General Universitario | Albacete | 02006 | Spain |
| Hospital Del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario de Cabueñes | Gijón | 33394 | Spain |
| Hospital General Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Universitario de León | León | 24001 | Spain |
| Hospital Universitario Lucus Agusti | Lugo | 27003 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | 28222 | Spain |
| Hospital Universitario Virgen de La Victoria | Málaga | 29010 | Spain |
| Hospital Clinico Universitario Virgen Arrixaca | Murcia | 30120 | Spain |
| Hospital Universitario Marques de Valdcilla | Santander | 39008 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Background |
| 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. |
| 26864951 | Background | 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. |
| 28485275 | Background | 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. |
| 29246909 | Background | 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. |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided