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)

Fundación EPIC

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: Optimax stent®

Study type: Observational

Funder types: Other

Identifiers

NCT03737565

RETO 320

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

350 participants in 1 patient group

Coronary Artery Disease

Treatment:

Device: Optimax stent®