This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the procedure and to provide a reasonable enrolment period for the required data to be collected. The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 200 patients who underwent an endovascular intervention within standard-of-care (SOC) where at least 1 of the products (named above) from Cordis US Corp were used.
Treatment of coronary artery disease (CAD) is dependent on percutaneous coronary intervention (PCI). PCI includes a group of minimally invasive (non-surgical) procedures to treat narrowing of the coronary arteries and therefore restore arterial blood flow. PCI techniques have significantly improved over time1 and requires cardiac catherterization and an experienced physician. In the field of catheters, there are a variety of options from Diagnostic Catheters, Guiding Catheters, Guidewires or even Transradial Acces Devices1-5. All devices have different advantages and disadvantages and an appropriate selection is a requirement for successful angioplasty of coronary artery lesions2,3. Which device to choose depends on the anatomy of the vessel, the type of lesion and the technique used for the treatment. The different Catheters and Access Devices (Diagnostic Catheters, Guiding Catheters, Guidewires and Transradial Acces Devices) have proven their functionality and safety over the years and have become widely accepted supportive devices for the treatment of coronary atery disease. For example, the technical sucess for Diagnostic Catheters is high with about 95% technical success and about 100% procedural succes6-17. In this regard, the purpose of the current post market surveillance trial is to assess the safety and efficacy of different devices from Cordis (Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Cathheters, and Cordis Guidewires). The devices under investigation in the current study are the Adroit Guiding Catheter, Cordis Transradial Access Devices (RAIN Sheath and Avanti Plus Transradial Kit), Cordis Diagnostic Cathheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F, Infiniti 5F/6F, Tempo 4F, Tempo Aqua, High Flow and Pigtail Straightener), Cordis Guidewires (ATW, Stabilizer, Wizdom), which are described in detail in section 3.1.
Study Type
OBSERVATIONAL
Enrollment
Kepler Universitätsklinikum GmbH
Linz, Austria
Ordensklinikum Linz GmbH
Linz, Austria
ST. Poelten
Sankt Pölten, Austria
Klinik Favoriten
Vienna, Austria
Primary Safety Endpoint: Freedom from Serious Adverse Events and Serious Adverse Device Effects
Freedom from SAEs and SADEs during the procedure and up to 30 days after the procedure
Time frame: 30 days after procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Adroit Guiding Catheter according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Transradial Access Device RAIN Sheath according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Transradial Access Device Avanti Plus Transradial Kit according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque MB according to the IFU and without device related deficiencies
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200
Klinik Floridsdorf
Vienna, Austria
Klinikum Wels Grieskirchen
Wels, Austria
VZW Jessa Ziekenhus
Hasselt, Belgium
AZ Sint Nikolaas
Sint-Niklaas, Belgium
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque Plus according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Infiniti 4F according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Infiniti 5F/6F according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Tempo 4F according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Tempo Aqua according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter High FLow according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Pigtail Straightener according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire ATW according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire Stabilizer according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire Wizdom according to the IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Vista Brite Tip Guiding Catheter according to the respective IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device RAILWAY Shealthless Access System according to the respective IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device Avanti+ according to the respective IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device Brite - Tip according to the respective IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device Vista Brite IG according to the respective IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device Vessel Dilator according to the respective IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular closure device MynxGrip according to the respective IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular closure device Mynx Control according to the respective IFU and without device related deficiencies
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis Guidewire Emerald according to the respective IFU and without device related deficiencies.
Time frame: 30 days post procedure