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)

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Optimax stent®

• Registration Number: NCT03737565
• Lead Sponsor: Fundación EPIC

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Study Start: 2019-02-17
• Primary Completion: 2025-01-02
• Study Completion: 2025-01-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease	Optimax stent®	-

Primary Outcome Measures

Name	Time	Method
Safety. The number of composite events of cardiac.	6 and 12 month	The number of composite events of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
Efficacy: Incidence of clinically driven target lesion revascularization (TLR).	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 Outcome Measures

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

Trial Locations

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

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain