Clinical trial NCT03809715: Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)
Official title: Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 3520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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".

Brief summary: 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.

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

Primary outcomes:
measure: Target Lesion Revascularization (TLR) rate at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)
timeFrame: 12 months
measure: Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)
timeFrame: 12 months
measure: Stent thrombosis rates accumulated up to 12 months
timeFrame: 12 months
measure: Rate of bleeding complications accumulated up to 12 months
timeFrame: 12 months
measure: Technical/procedural success rate
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Rouen
country: France
facility: Clinique St. Hilaire
Study officials:
affiliation: Clinique St. Hilaire
name: Rene Koning, MD
role: PRINCIPAL_INVESTIGATOR
References: