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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)

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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®

Trial contacts and locations

5

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Central trial contact

Fundación EPIC

Data sourced from clinicaltrials.gov

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