Coronary ArteriosclerosisNCT06678490
Support C Post-Market Registry
An observational study of Coronary Arteriosclerosis, run by OrbusNeich at 12 sites in 4 countries.
Trial summary
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter 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 Arteriosclerosis
- How many people
- 282 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 9 Jul 2025to Feb 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 ischemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses can be included in the study. The vessel diameter must be 2.0 - 4.0 mm.
Who may be able to join
- Consecutive patients intended to be, or treated by Support C DCB as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.
- Note:
- In case of major dissection requiring bailout stenting after DCB use the patients will be included in the registry and followed as per study schedule.
- If major dissection occurred after lesion preparation, but before DCB use and lesion was stented, the patient will not be included in the registry.
Who cannot join
- Patients are excluded if ANY of the following additional 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
12 sites in 4 countries.
12 sites in 4 countries
Spain5 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitario Virgen del Rocío
Seville, 41013
Germany4 sites
Katholischen Krankenhaus "St. Johann Nepomuk"
Erfurt, 99097
Evangelisches Krankenhaus Hagen-Haspe gGmbH
Hagen, 58135
MediClin Herzzentrum Lahr
Lahr, 77933
Martha Maria Nürnberg
Nuremberg, 90491
Czechia2 sites
Krajska nemocnice Liberec
Liberec, 46001
Motol University Hospital
Prague, 15006
Malaysia1 site
National Heart Institute (Institut Jantung Negara)
Kuala Lumpur, 50400
About this study
Official title: PMCF Registry Study Paclitaxel-eluting Balloon Catheter Support C
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.
Read the detailed description
This 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 Support C Drug Coated Balloon (DCB) according to the Instructions for Use as part of routine clinical care. Approximately 278 patients from 8-12 centers in Europe will be entered into the registry. Patients in 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, 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.
- Conditions
- Coronary Arteriosclerosis
- Keywords
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arterioscherosis, Cardiovascular Diseases, Drug Coated Balloon, Ischemic Heart Disease
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting SUPPORT C PTCA balloon catheter | The Drug Eluting SUPPORT C PTCA balloon catheter is indicated for use in patients with symptomatic ischaemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses. |
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 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) (by PCI or coronary artery bypass grafting).
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, 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), and 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) a composite of all 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 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
Adjudicated lesion thrombosis
Measured: through hospital discharge (expected to be within 24 hours), 30 days, 6 months, 12 months, 24 months, and 36 months
Device success
Successful reaching of the target lesion, successful inflation and deflation of the balloon catheter, and a final residual stenosis after DCB treatment of ≤30% by visual assessment in the presence of grade 3 TIMI (Thrombolysis in Myocardial Infarction) flow, by visual estimation.
Measured: Index Procedure
Procedure success
Procedure success: Successful balloon delivery, deployment and retrieval and no peri-procedural death, TV-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 posted7 Nov 2024
- Study start9 Jul 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies 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
- 282 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- OrbusNeich
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eucatech AG, European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Fernando Alfonso, MD, PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678490
- Sponsor's protocol ID
- DVAL-PLAN-063
- Status last verified
- Jan 2026
- First submitted
- 6 Nov 2024
- Last updated
- 10 Feb 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMCF Registry Study Paclitaxel-eluting Balloon Catheter Support C
- ClinicalTrials.gov ID
- NCT06678490
- Acronym / sponsor ID
- DVAL-PLAN-063
- Conditions
- Coronary Arteriosclerosis
- Keywords
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arterioscherosis, Cardiovascular Diseases, Drug Coated Balloon, Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 282 participants (actual)
- Lead sponsor
- OrbusNeichIndustry (pharma, biotech, devices)
- Collaborators
- Eucatech AG, European Cardiovascular Research Center
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 7 Nov 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 drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Support C Drug Coated Balloon (DCB) in routine clinical practice.
Detailed description
This 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 Support C Drug Coated Balloon (DCB) according to the Instructions for Use as part of routine clinical care. Approximately 278 patients from 8-12 centers in Europe will be entered into the registry. Patients in 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, 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 |
|---|---|---|
| Drug Eluting SUPPORT C PTCA balloon catheter | – | –The Drug Eluting SUPPORT C PTCA balloon catheter is indicated for use in patients with symptomatic ischaemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic ischemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses can be included in the study. The vessel diameter must be 2.0 - 4.0 mm.
Key inclusion criteria (4 listed)
- Consecutive patients intended to be, or treated by Support C DCB as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.
- In case of major dissection requiring bailout stenting after DCB use the patients will be included in the registry and followed as per study schedule.
- If major dissection occurred after lesion preparation, but before DCB use and lesion was stented, the patient will not be included in the registry.
Key exclusion criteria (5 listed)
- Patients are excluded if ANY of the following additional 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.
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 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) (by PCI or coronary artery bypass grafting).
9 secondary outcomes
Adjudicated Target Lesion Failure (TLF)
Time frame: through hospital discharge (expected to be within 24 hours), 30 days, 6 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), and 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) a composite of all 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 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
Adjudicated lesion thrombosis
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 10 Feb 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.
Fernando Alfonso, MD, PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteriosclerosis, run by OrbusNeich at 12 sites in 4 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 4 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Germany, 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 10 Feb 2026.