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)

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03737565

Acronym

RETO 320

Enrollment

350

Registered

2018-11-09

Start date

2019-02-17

Completion date

2025-01-02

Last updated

2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Cobalt-chromium

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.

Interventions

DEVICEOptimax stent®

Percutaneous coronary intervention with Optimax stent®

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Safety. The number of composite events of cardiac.	6 and 12 month	The number of composite events of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
Efficacy: Incidence of clinically driven target lesion revascularization (TLR).	6 and 12 month	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.

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026