NCT03809715Completed
Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)
Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3520 (actual)
- First submitted
- 17 Jan 2019
- Start date
- 17 Jan 2019
- Primary completion date
- 31 May 2024
- Lead sponsor
- B. Braun Melsungen AG
- Diseases
- Coronary artery disease
- NCT number
- NCT03809715
What you commit to
- Study type: Observational
- Participants enrolled: 3520
- From 17 Jan 2019 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for a bypass surgery
- Contraindication for whichever accompanying medication is necessary
Other illness
- Allergy to components of the coating
- Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
- Severe allergy to contrast media
Lab values
- 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
- Patients with an ejection fraction of \< 30 %
Other
- Intolerance to sirolimus and/or probucol
- Pregnancy and lactation
- Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
- Cardiogenic shock
- Risk of an intraluminal thrombus
- Lesions which are untreatable with PCI or other interventional techniques
- Vascular reference diameter \< 2.00 mm
- Treatment of the left stem (first section of the left coronary artery)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique St. Hilaire Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.