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 Optimax® stent.
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent in de novo coronary lesions with reference diameter ≥ 3.0 mm and Length ≤ 20 mm.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimax stent® | Device | Percutaneous coronary intervention with Optimax stent® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety. The number of composite events of cardiac. | The number of composite events of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). | 6 and 12 month |
| Efficacy: Incidence of clinically driven target lesion revascularization (TLR). | Incidence of clinically driven target lesion revascularization (TLR).Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 6 and 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| All death. | Systemic embolism, Major bleeding event (BARC ≥ 2). | 6 and 12 month |
| Cardiac death. | Cardiac death. | 6 and 12 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mérida | Mérida | Badajoz | 06800 | Spain | ||
| Hospital Universitario Vall d'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28963751 | Result | Lopez-Minguez JR, Nogales-Asensio JM, Romani S, Rivero-Crespo F, Aragon-Extremera VM, Jimenez-Mazuecos JM, Carrasco F, Oteo-Dominguez JF, Bosa-Ojeda F, Gomez-Hospital JA. TIOMAX: A Spanish Multicenter Registry of the real-world use of the TItanium OptiMAX(R) biostent: TIOMAX: Registro Espanol Multicentrico Del Biostent De Titanio OptiMAX(R) En La Vida Real. Catheter Cardiovasc Interv. 2018 Aug 1;92(2):261-268. doi: 10.1002/ccd.27326. Epub 2017 Sep 30. | |
| 27497110 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Target Vessel revascularization. | Target Vessel revascularization. | 6 and 12 month |
| Target lesion revascularization. | Target lesion revascularization. | 6 and 12 month |
| Stent thrombosis (ARC definite/probable). | Stent thrombosis (ARC definite/probable). | 6 and 12 month |
| Major bleeding event (BARC type 2-5). | Major bleeding event (BARC type 2-5). | 6 and 12 month |
| Stroke. | Stroke. | 6 and 12 month |
| Barcelona |
| 08035 |
| Spain |
| Hospital San Pedro de Alcántara | Cáceres | 10003 | Spain |
| Hospital Universitario de León | León | 24080 | Spain |
| Hospital Universitari Arnau de Vilanova | Lleida | 25198 | Spain |
| Result |
| Karjalainen PP, Nammas W, Ylitalo A, de Bruyne B, Lalmand J, de Belder A, Rivero-Crespo F, Kervinen K, Airaksinen JKE. Long-term clinical outcome of titanium-nitride-oxide-coated stents versus everolimus-eluting stents in acute coronary syndrome: Final report of the BASE ACS trial. Int J Cardiol. 2016 Nov 1;222:275-280. doi: 10.1016/j.ijcard.2016.07.267. Epub 2016 Aug 1. |
| 25670057 | Result | Colkesen EB, Eefting FD, Rensing BJ, Suttorp MJ, Ten Berg JM, Karjalainen PP, Van Der Heyden JA. TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives. Minerva Cardioangiol. 2015 Feb;63(1):21-9. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided