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)

January 20, 2022 updated by: Fundación EPIC

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
      • Cáceres, Spain, 10003
        • Not yet recruiting
        • Hospital San Pedro de Alcantara
      • León, Spain, 24080
        • Recruiting
        • Hospital Universitario de Leon
      • Lleida, Spain, 25198
        • Not yet recruiting
        • Hospital Universitari Arnau de Vilanova
    • Badajoz
      • Mérida, Badajoz, Spain, 06800
        • Not yet recruiting
        • Hospital de Merida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Artery Disease
Device: Optimax stent®
Percutaneous coronary intervention with Optimax stent®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 and 12 month
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.
6 and 12 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2019

Primary Completion (Anticipated)

March 15, 2022

Study Completion (Anticipated)

April 15, 2022

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETO 320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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