Coronary Artery DiseaseNCT03809715
Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)
An observational study of Coronary Artery Disease, run by B. Braun Melsungen AG at 1 site in France.
Trial summary
The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions. 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?
- Coroflex® ISAR NEO coronary stent system
- Type of treatment
- Medical device
- How many people
- 3,520 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2019to 15 Aug 2025
- 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
- Adult, Older adult
Study population: The investigator of each study site has the responsibility of screening all potential patients and selecting those who fulfil the inclusion criteria of this study protocol. Therefore, at each site a study with similar inclusion criteria cannot be conducted while the recruitment of this study is in progress. Screening will be performed during the physical examination to verify the "patient related enrolment criteria". The second part of the screening procedure will be completed during the diagnostic angiography to verify that the target lesion fulfils all "lesion related enrolment criteria".
Who may be able to join
- Coroflex® ISAR NEO is intended to be used for
- All common significant coronary lesions
- Target lesion length >34mm need to be covered with at least 2 stents
- Patients eligible for this study must be at least 18 years of age.
- The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.
Who cannot join
- Intolerance to sirolimus and/or probucol
- Allergy to components of the coating
- Pregnancy and lactation
- Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
- Cardiogenic shock
- Risk of an intraluminal thrombus
Show all 15Show fewer
- Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
- Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
- Severe allergy to contrast media
- Lesions which are untreatable with PCI or other interventional techniques
- Patients with an ejection fraction of < 30 %
- Vascular reference diameter < 2.00 mm
- Treatment of the left stem (first section of the left coronary artery)
- Indication for a bypass surgery
- Contraindication for whichever accompanying medication is necessary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo
The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.
Read the detailed description
Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.
- Conditions
- Coronary Artery Disease
- Being tested
- Coroflex® ISAR NEO coronary stent system
- 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.
Coroflex® ISAR NEO coronary stent systemDevice
treatment of coronary artery disease with Coroflex® ISAR NEO of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Revascularization (TLR) rate at 12 months
Measured: 12 months
Secondary outcomes (5)
Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)
MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.
Measured: 12 months
Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)
Measured: 12 months
Stent thrombosis rates accumulated up to 12 months
Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.
Measured: 12 months
Rate of bleeding complications accumulated up to 12 months
To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.
Measured: 12 months
Technical/procedural success rate
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start17 Jan 2019
- Primary completion31 May 2024
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rene Koning, MD, Principal investigator, Clinique St. Hilaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809715
- Sponsor's protocol ID
- AAG-O-H-1803
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2019
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landolff Q, Quillot M, Picard F, Henry P, Sideris G, Bizeau O, Piot C, Jouve B, Rischner J, Mejri M, Charmasson C, Lasserre R, Pouliquen H, Joseph T, Monsegu J, Karsenty B, Martin Yuste V, Richet N, Lapeyre G, Beverelli F, Beygui F, Koning R. In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease. J Interv Cardiol. 2023 Dec 13;2023:8907315. doi: 10.1155/2023/8907315. eCollection 2023.
PubMed 38125031
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo
- ClinicalTrials.gov ID
- NCT03809715
- Acronym / sponsor ID
- AAG-O-H-1803
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,520 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 18 Jan 2019 (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.
The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.
Detailed description
Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigator of each study site has the responsibility of screening all potential patients and selecting those who fulfil the inclusion criteria of this study protocol. Therefore, at each site a study with similar inclusion criteria cannot be conducted while the recruitment of this study is in progress. Screening will be performed during the physical examination to verify the "patient related enrolment criteria". The second part of the screening procedure will be completed during the diagnostic angiography to verify that the target lesion fulfils all "lesion related enrolment criteria".
Key inclusion criteria (5 listed)
- Coroflex® ISAR NEO is intended to be used for
- All common significant coronary lesions
- Target lesion length >34mm need to be covered with at least 2 stents
- Patients eligible for this study must be at least 18 years of age.
- The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.
Key exclusion criteria (15 listed)
- Intolerance to sirolimus and/or probucol
- Allergy to components of the coating
- Pregnancy and lactation
- Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
- Cardiogenic shock
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 |
|---|---|---|
| Coroflex® ISAR NEO coronary stent systemtreatment of coronary artery disease with Coroflex® ISAR NEO of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts | Device | – |
Primary outcome
Target Lesion Revascularization (TLR) rate at 12 months
Time frame: 12 months
5 secondary outcomes
Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)
Time frame: 12 months
Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)
Time frame: 12 months
Stent thrombosis rates accumulated up to 12 months
Time frame: 12 months
Rate of bleeding complications accumulated up to 12 months
Time frame: 12 months
Technical/procedural success rate
Time frame: immediately after procedure
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 8 Jan 2026.
- Derived from this study: PubMed 38125031Landolff Q, Quillot M, Picard F, Henry P, Sideris G, Bizeau O, Piot C, Jouve B, Rischner J, Mejri M, Charmasson C, Lasserre R, Pouliquen H, Joseph T, Monsegu J, Karsenty B, Martin Yuste V, Richet N, Lapeyre G, Beverelli F, Beygui F, Koning R. In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease. J Interv Cardiol. 2023 Dec 13;2023:8907315. doi: 10.1155/2023/8907315. eCollection 2023.
- 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.
Rene Koning, MD principal investigator
Clinique St. Hilaire
1 site 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 B. Braun Melsungen AG at 1 site in France.
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 5 inclusion and 15 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Target Lesion Revascularization (TLR) rate at 12 months (time frame: 12 months). 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 NCT03809715, which also lists 1 linked publication.
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 8 Jan 2026.