NCT05543096

PMCF Study for Cardiology Access Procedures

A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the Adroit Guiding Catheter, the Cordis Transradial Access Devices (RAIN Sheath and Avanti Plus Transradial Kit), the Cordis Diagnostic Catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F, Infiniti 5F/6F, Tempo 4F, Tempo Aqua, High Flow and Pigtail Straightener) and the Cordis Guidewires (ATW, Stabilizer and Wizdom) for Percutaneous Coronary Interventions.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires	Observation

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-08-31
• Completion: 2022-09-07
• First posted: 2022-09-16
• Last updated: 2023-07-28

Locations

8 sites across 2 countries: Austria, Belgium