Coronary ArteriosclerosesNCT06621524
EucaLimus Post-Market Registry
An observational study of Coronary Arterioscleroses, run by OrbusNeich at 10 sites in 3 countries.
Trial summary
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the Eucalimus sirolimus eluting PTCA stent when used according to the Instructions for Use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterioscleroses
- What is being tested?
- EucaLimus coronary stent system
- Type of treatment
- Medical device
- How many people
- 251 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 14 Mar 2025to Jan 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 symptomatic ischaemic coronary heart disease due to de novo lesions or restenosis lesions of the coronary arteries, or patients with acute or suspected occlusions who responded unsuccessfully to an interventional therapy following balloon dilatation.
Who may be able to join
- Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.
Who cannot join
- Patients are excluded from registration if ANY of the following conditions apply:
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
- A life expectancy of <1year
- Explicit refusal of participation in the registry
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Spain7 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitario Reina Sofía
Córdoba, 14004
Bellvitge University Hospital
L'Hospitalet de Llobregat, Catalonia, 08907
Hospital Universitario Lucus Augusti
Lugo, 27003
Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, 38320
Hospital Universitario Joan XXIII
Tarragona, 43005
Czechia2 sites
Krajska nemocnice Liberec
Liberec, 46001
Motol University Hospital
Prague, 15006
About this study
Official title: Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease: a PMCF Study.
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the Eucalimus sirolimus eluting PTCA stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Eucalimus PTCA stent in routine clinical practice.
Read the detailed description
The multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Eucalimus sirolimus eluting PTCA stent (according to the Instructions for Use) as part of routine clinical care. Approximately 251 patients from 5-10 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.
A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.
- Conditions
- Coronary Arterioscleroses
- Being tested
- EucaLimus coronary stent system
- Keywords
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases, Drug-Coated Stent, Ischemic Heart Disease
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EucaLimus coronary stent systemDevice
The EucaLimus coronary stent system is a drug-coated coronary stent system, indicated for use in patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosed lesions of the coronary arteries.
| Study group | Role | What they receive |
|---|---|---|
| Device: EucaLimus coronary stent system | The EucaLimus coronary stent system is a drug-coated coronary stent system, indicated for use in patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosed lesions of the coronary arteries. Receives: Device: EucaLimus coronary stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjudicated, device-oriented, Target Lesion Failure (TLF)
Adjudicated, device-oriented, Target Lesion Failure (TLF) where TLF is defined (Academic Research Consortium- ARC) as a composite of cardiac death (CD), non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel (TV-MI) or clinically driven target lesion revascularization (cd-TLR).
Measured: 12 months post procedure
Secondary outcomes (9)
Adjudicated Target Lesion Failure (TLF)
Measured: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Each of the components of TLF (Cardiac Death (CD), non-fatal myocardial infarction not clearly attributable to a non-target vessel (TV-MI), clinically driven target lesion revascularization (cd-TLR))
Measured: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated Target Vessel Failure (TVF) (ARC definition) as a composite of Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR)
Measured: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Each of the components of TVF (Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR))
Measured: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated stent thrombosis per ARC-2 definition
Measured: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated bleeding Type 3-5 per the Bleeding Academic Research Consortium (BARC) definition
Measured: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated stroke
Measured: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Device success
Device success: Percentage of patients with a successful delivery and deployment of the EucaLimus stent at the target lesion and final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI (Thrombolysis in Myocardial Infarction) flow, by visual estimation EucaLimus stent at the target lesion and a final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI flow, by visual estimation
Measured: Index Procedure
Procedure Success
Procedure Success: Device success and no peri-procedural death, MI or TVR.
Measured: Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start14 Mar 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- OrbusNeich
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eucatech AG, Centre Européen de Recherche Cardiovasculaire
- Responsible party
- Sponsor
- Investigators
- Josep Gomez-Lara, MD, PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621524
- Sponsor's protocol ID
- DVAL-PLAN-0062
- Status last verified
- Mar 2026
- First submitted
- 27 Sep 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease: a PMCF Study.
- ClinicalTrials.gov ID
- NCT06621524
- Acronym / sponsor ID
- DVAL-PLAN-0062
- Conditions
- Coronary Arterioscleroses
- Keywords
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases, Drug-Coated Stent, Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 251 participants (actual)
- Lead sponsor
- OrbusNeichIndustry (pharma, biotech, devices)
- Collaborators
- Eucatech AG, Centre Européen de Recherche Cardiovasculaire
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 1 Oct 2024 (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.
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the Eucalimus sirolimus eluting PTCA stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Eucalimus PTCA stent in routine clinical practice.
Detailed description
The multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Eucalimus sirolimus eluting PTCA stent (according to the Instructions for Use) as part of routine clinical care. Approximately 251 patients from 5-10 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.
A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: EucaLimus coronary stent system | – | Device: EucaLimus coronary stent systemThe EucaLimus coronary stent system is a drug-coated coronary stent system, indicated for use in patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosed lesions of the coronary arteries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosis lesions of the coronary arteries, or patients with acute or suspected occlusions who responded unsuccessfully to an interventional therapy following balloon dilatation.
Key inclusion criteria (1 listed)
- Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.
Key exclusion criteria (5 listed)
- Patients are excluded from registration if ANY of the following conditions apply:
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 |
|---|---|---|
| EucaLimus coronary stent systemThe EucaLimus coronary stent system is a drug-coated coronary stent system, indicated for use in patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosed lesions of the coronary arteries. | Device | Device: EucaLimus coronary stent system |
Primary outcome
Adjudicated, device-oriented, Target Lesion Failure (TLF)
Time frame: 12 months post procedure
Adjudicated, device-oriented, Target Lesion Failure (TLF) where TLF is defined (Academic Research Consortium- ARC) as a composite of cardiac death (CD), non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel (TV-MI) or clinically driven target lesion revascularization (cd-TLR).
9 secondary outcomes
Adjudicated Target Lesion Failure (TLF)
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Each of the components of TLF (Cardiac Death (CD), non-fatal myocardial infarction not clearly attributable to a non-target vessel (TV-MI), clinically driven target lesion revascularization (cd-TLR))
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated Target Vessel Failure (TVF) (ARC definition) as a composite of Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR)
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Each of the components of TVF (Cardiovascular Death (CVD), TV-MI and clinically driven target vessel revascularization (cd-TVR))
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated stent thrombosis per ARC-2 definition
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated bleeding Type 3-5 per the Bleeding Academic Research Consortium (BARC) definition
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Adjudicated stroke
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Device success
Time frame: Index Procedure
Procedure Success
Time frame: Index Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Josep Gomez-Lara, MD, PhD principal investigator
Hospital Universitari de Bellvitge
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterioscleroses, run by OrbusNeich at 10 sites in 3 countries.
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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Czechia, Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adjudicated, device-oriented, Target Lesion Failure (TLF) (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.