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)

Coronary Artery Disease Clinical Trial

— RETO 320  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03737565
• Other study ID #: RETO 320
• Status: Recruiting
• Start date: February 17, 2019
• Est. completion date: April 15, 2022

Study information

• Verified date: August 2021
• Source: Fundación EPIC
• Contact: Fundación EPIC
• Phone: +34987876135
• Email: admin[@]fundacionepic.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Optimax stent®
Percutaneous coronary intervention with Optimax stent®

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Universitario de León	León
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital de Mérida	Mérida	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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 — View 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 re — View Citation

López-Mínguez JR, Nogales-Asensio JM, Romani S, Rivero-Crespo F, Aragón-Extremera VM, Jiménez-Mazuecos JM, Carrasco F, Oteo-Domínguez JF, Bosa-Ojeda F, Gómez-Hospital JA. TIOMAX: A Spanish Multicenter Registry of the real-world use of the TItanium OptiMAX — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	All death.	Systemic embolism, Major bleeding event (BARC = 2).	6 and 12 month
Secondary	Cardiac death.	Cardiac death.	6 and 12 month
Secondary	Target Vessel revascularization.	Target Vessel revascularization.	6 and 12 month
Secondary	Target lesion revascularization.	Target lesion revascularization.	6 and 12 month
Secondary	Stent thrombosis (ARC definite/probable).	Stent thrombosis (ARC definite/probable).	6 and 12 month
Secondary	Major bleeding event (BARC type 2-5).	Major bleeding event (BARC type 2-5).	6 and 12 month
Secondary	Stroke.	Stroke.	6 and 12 month