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NCT Number: NCT03737565

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)

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Mérida, Mérida, Badajoz, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Optimax stent®

Device

Percutaneous coronary intervention with Optimax stent®

Primary outcomes

  1. Safety. The number of composite events of cardiac.

    Time frame: 6 and 12 month

    The number of composite events of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).

  2. Efficacy: Incidence of clinically driven target lesion revascularization (TLR).

    Time frame: 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 outcomes

  1. All death.

    Time frame: 6 and 12 month

    Systemic embolism, Major bleeding event (BARC ≥ 2).

  2. Cardiac death.

    Time frame: 6 and 12 month

    Cardiac death.

  3. Target Vessel revascularization.

    Time frame: 6 and 12 month

    Target Vessel revascularization.

  4. Target lesion revascularization.

    Time frame: 6 and 12 month

    Target lesion revascularization.

  5. Stent thrombosis (ARC definite/probable).

    Time frame: 6 and 12 month

    Stent thrombosis (ARC definite/probable).

  6. Major bleeding event (BARC type 2-5).

    Time frame: 6 and 12 month

    Major bleeding event (BARC type 2-5).

  7. Stroke.

    Time frame: 6 and 12 month

    Stroke.

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study 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)

Acronym: RETO 320

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2018
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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