Clinical trial NCT03737565: Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm)
Official title: Prospective, Multicenter and Observational Registry for the Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm) (Reto 320 Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Cobalt-chromium
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.

Brief summary: This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with age ≥ 18 years old.
* Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.
* Informed consent signed.

Exclusion Criteria:

* Refusal of the patient to participate at the study.
* Treatment of other injuries that do not meet the conditions (3x20).

Primary outcomes:
measure: Safety. The number of composite events of cardiac.
timeFrame: 6 and 12 month
measure: Efficacy: Incidence of clinically driven target lesion revascularization (TLR).
timeFrame: 6 and 12 month
Secondary outcomes:
measure: All death.
timeFrame: 6 and 12 month
measure: Cardiac death.
timeFrame: 6 and 12 month
measure: Target Vessel revascularization.
timeFrame: 6 and 12 month
measure: Target lesion revascularization.
timeFrame: 6 and 12 month
measure: Stent thrombosis (ARC definite/probable).
timeFrame: 6 and 12 month
measure: Major bleeding event (BARC type 2-5).
timeFrame: 6 and 12 month
measure: Stroke.
timeFrame: 6 and 12 month
Other outcomes:
Locations:
city: Mérida
country: Spain
facility: Hospital de Mérida
state: Badajoz
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: León
country: Spain
facility: Hospital Universitario de León
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.