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)

NCT ID: NCT03737565

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-17

Study Completion Date

2025-01-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Artery Disease

Optimax stent®

Intervention Type DEVICE

Percutaneous coronary intervention with Optimax stent®

Interventions

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Optimax stent®

Percutaneous coronary intervention with Optimax stent®

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación EPIC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de Mérida

Mérida, Badajoz, Spain

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital San Pedro de Alcántara

Cáceres, , Spain

Site Status

Hospital Universitario de León

León, , Spain

Site Status

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Site Status

Countries

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Spain

References

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Lopez-Minguez JR, Nogales-Asensio JM, Romani S, Rivero-Crespo F, Aragon-Extremera VM, Jimenez-Mazuecos JM, Carrasco F, Oteo-Dominguez JF, Bosa-Ojeda F, Gomez-Hospital JA. TIOMAX: A Spanish Multicenter Registry of the real-world use of the TItanium OptiMAX(R) biostent: TIOMAX: Registro Espanol Multicentrico Del Biostent De Titanio OptiMAX(R) En La Vida Real. Catheter Cardiovasc Interv. 2018 Aug 1;92(2):261-268. doi: 10.1002/ccd.27326. Epub 2017 Sep 30.

Reference Type RESULT
PMID: 28963751 (View on PubMed)

Karjalainen PP, Nammas W, Ylitalo A, de Bruyne B, Lalmand J, de Belder A, Rivero-Crespo F, Kervinen K, Airaksinen JKE. Long-term clinical outcome of titanium-nitride-oxide-coated stents versus everolimus-eluting stents in acute coronary syndrome: Final report of the BASE ACS trial. Int J Cardiol. 2016 Nov 1;222:275-280. doi: 10.1016/j.ijcard.2016.07.267. Epub 2016 Aug 1.

Reference Type RESULT
PMID: 27497110 (View on PubMed)

Colkesen EB, Eefting FD, Rensing BJ, Suttorp MJ, Ten Berg JM, Karjalainen PP, Van Der Heyden JA. TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives. Minerva Cardioangiol. 2015 Feb;63(1):21-9.

Reference Type RESULT
PMID: 25670057 (View on PubMed)

Other Identifiers

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RETO 320

Identifier Type: -

Identifier Source: org_study_id

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