BioMatrix NeoFlex Post Marketing Surveillance in Validate (the BASIC VALIDATE) Registry)

Purpose of the study The purpose of this registry is to capture clinical data of the BioMatrix NeoFlex™ stent (an improved version of the delivery system of the Biolimus A9™-eluting BioMatrix Flex stent) in relation to safety and effectiveness in the VALIDATE SWEDEHEART trial and in a group of patients not taking part in VALIDATE SWEDEHEART in addition to a group of patients with stable angina pectoris.

Clinical relevance The European Union has a focus on and encourages the conductance of post marketing surveillance studies of medical devices 3. This focus should be seen in the light of limitations to clinical data available in the pre-market phase owing to duration of pre-market clinical investigations, the number of subjects and investigators involved in an investigation, the relative heterogeneity of subjects and investigators and the controlled setting of a clinical investigation versus the full range of clinical conditions encountered in general medical practice. The extent of the data that can be gathered in the pre-market phase does not necessarily enable detection of rare complications or problems that only become apparent after widespread or long term use of the device. Because the study device (BioMatrix NeoFlex™) is a CE-marked updated version of the BioMatrix Flex stent it is important to document that the assumed improvements in delivery design also reflect improvements in a clinical setting.

Patients and methods

Patients A total of 6000 patients will be included in the VALIDATE SWEDEHEART trial. 3000 STEMI and 3000 NSTEMI. The ambition is that approximately 1000 of these patients are also included in the BASIC VALIDATE stent registry. In addition, and in order to achieve post-market information from the entire spectrum of PCI, another 1000 patients with stable angina pectoris, STEMI or NSTEMI will be included in the registry at VALIDATE SWEDEHEART centers but unrelated to the VALIDATE SWEDEHEART trial.

Treatment strategy During the index procedure, only BioMatrix NeoFlex™ stents will be implanted. The investigator will choose the appropriate length and diameter of the stents to be implanted by visual estimate. The choice of the length of the stent should ensure complete coverage of the lesion. In case of insufficient stent expansion, post-dilatation is highly recommended. In the event that a staged procedure is expected or planned it is recommended NOT to include the patient in the BASIC VALIDATE registry because the nature of follow-up of patients (registry only) means that staged procedures will be classified as events ("repeat" revascularizations).