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)

Fundación EPIC350 enrolled

Overview

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

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

350

Conditions

Coronary Artery Disease

Interventions

Optimax stent®DEVICE

Percutaneous coronary intervention with Optimax stent®

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (5)

Hospital de Mérida

Mérida, Badajoz, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital San Pedro de Alcántara

Cáceres, Spain

Hospital Universitario de León

León, Spain

Outcomes

Primary Outcomes

Safety. The number of composite events of cardiac.

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

Time frame: 6 and 12 month

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

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.

Time frame: 6 and 12 month

Secondary Outcomes

All death.

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

Time frame: 6 and 12 month

Cardiac death.

Time frame: 6 and 12 month

Target Vessel revascularization.

Time frame: 6 and 12 month

Target lesion revascularization.

Time frame: 6 and 12 month

Stent thrombosis (ARC definite/probable).

Time frame: 6 and 12 month

Major bleeding event (BARC type 2-5).

Data from ClinicalTrials.gov

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