Coronary Artery DiseaseRETO 320NCT03737565
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)
An observational study of Coronary Artery Disease, run by Fundación EPIC at 5 sites in Spain.
Trial summary
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Optimax stent®
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 5 sitesSpain
- Study dates
- 17 Feb 2019to 2 Jan 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.
Who may be able to join
- 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.
Who cannot join
- Refusal of the patient to participate at the study.
- Treatment of other injuries that do not meet the conditions (3x20).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital San Pedro de Alcántara
Cáceres, 10003
Hospital Universitario de León
León, 24080
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Hospital de Mérida
Mérida, Badajoz, 06800
About this study
Official 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)
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Optimax stent®
- Keywords
- Cobalt-chromium
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimax stent®Device
Percutaneous coronary intervention with Optimax stent®
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease | Not described Receives: Device: Optimax stent® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 and 12 month
Secondary outcomes (7)
All death.
Systemic embolism, Major bleeding event (BARC ≥ 2).
Measured: 6 and 12 month
Cardiac death.
Cardiac death.
Measured: 6 and 12 month
Target Vessel revascularization.
Target Vessel revascularization.
Measured: 6 and 12 month
Target lesion revascularization.
Target lesion revascularization.
Measured: 6 and 12 month
Stent thrombosis (ARC definite/probable).
Stent thrombosis (ARC definite/probable).
Measured: 6 and 12 month
Major bleeding event (BARC type 2-5).
Major bleeding event (BARC type 2-5).
Measured: 6 and 12 month
Stroke.
Stroke.
Measured: 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start17 Feb 2019
- Primary completion2 Jan 2025
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737565
- Sponsor's protocol ID
- RETO 320
- Acronym
- RETO 320
- Status last verified
- Mar 2025
- First submitted
- 8 Nov 2018
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28963751Karjalainen 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.
PubMed 27497110Colkesen 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.
PubMed 25670057
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03737565
- Acronym / sponsor ID
- RETO 320 / RETO 320
- Conditions
- Coronary Artery Disease
- Keywords
- Cobalt-chromium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 17 Feb 2019 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease | – | Device: Optimax stent® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal of the patient to participate at the study.
- Treatment of other injuries that do not meet the conditions (3x20).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimax stent®Percutaneous coronary intervention with Optimax stent® | Device | Coronary Artery Disease |
Primary outcome
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).
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.
7 secondary outcomes
All death.
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).
Time frame: 6 and 12 month
Stroke.
Time frame: 6 and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Results publication: PubMed 28963751Lopez-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.
- Results publication: PubMed 27497110Karjalainen 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.
- Results publication: PubMed 25670057Colkesen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Fundación EPIC at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The number of composite events of cardiac. (time frame: 6 and 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737565, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.