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)

NCT03737565 | Completed

• 1 other identifier: RETO 320
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Cobalt-chromium

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• All death.

  6 and 12 month

• Cardiac death.

  6 and 12 month

• Target Vessel revascularization.

  6 and 12 month

• Target lesion revascularization.

  6 and 12 month

• Stent thrombosis (ARC definite/probable).

  6 and 12 month

Study Arms (1)

Coronary Artery Disease

Device: Optimax stent®

Interventions

Optimax stent® DEVICE

Percutaneous coronary intervention with Optimax stent®

Coronary Artery Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (5)

Hospital de Mérida

Mérida, Badajoz, 06800, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Hospital Universitario de León

León, 24080, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Related Publications (3)

• 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.

  PMID: 28963751 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.

  PMID: 27497110 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.

  PMID: 25670057 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 9, 2018
• Study Start: February 17, 2019
• Primary Completion: January 2, 2025
• Study Completion: January 2, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-03

Locations

ES (5)