Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)

Launched by B. BRAUN MELSUNGEN AG · Jan 17, 2019

Keywords

ClinConnect Summary

The Coroflex ISAR NEO clinical trial is looking at a specific medical device designed to treat blockages in the heart's arteries, which is a common problem known as coronary artery disease. The main goal of the study is to evaluate how safe and effective this device is for treating both new blockages and those that have reoccurred after previous treatments. This trial is currently active, meaning they are still collecting data, but they are not enrolling new participants at this time.

To be eligible for participation, individuals must be at least 18 years old and have significant blockages in their heart arteries that require treatment. Specifically, if the blockage is longer than 34 millimeters, they would need at least two stents (small tubes to keep the artery open). However, there are certain conditions that would exclude someone from participating, such as severe allergies, certain heart conditions, or if they are pregnant. Participants in this trial can expect to receive the Coroflex ISAR NEO device as part of their regular treatment plan, and their progress will be monitored over time to gather valuable information about its performance.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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
• • 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