PMCF Study for Cardiology Access Procedures

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT05543096
• Lead Sponsor: Cordis Corporation

Brief 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.

Study Timeline

• Study Start: 2022-05-23
• Study First Submitted: 2022-06-29
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-07
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-16
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for percutaneous coronary intervention (PCI).

2. Patient is >18 years old at the conduction of the procedure.

3. Patient is eligible for treatment with Adroit Guiding Catheter Cordis Transradial Access Devices

   • RAIN Sheath
   • 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
   • Pigtail Straightener Cordis Guidewires
   • ATW
   • Stabilizer
   • Wizdom as described in the IFU for each device.

Exclusion Criteria

1. Anatomy or size of vessels that did not allow appropriate usage of the study devices, following IFU of the study devices.
2. Known contraindication and/or allergy to (a component of) an study device as described in the IFU of the devices.
3. Women who were pregnant or lactating at the time of the procedure.
4. Any patient who was hemodynamically unstable at onset of procedure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment	30 days post procedure	Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire Wizdom according to the IFU and without device related deficiencies
Primary Safety Endpoint: Freedom from Serious Adverse Events and Serious Adverse Device Effects	30 days after procedure	Freedom from SAEs and SADEs during the procedure and up to 30 days after the procedure

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment	30 days post procedure	Technical success rate defined as successful crossing, introduction and deployment of Cordis Guidewire Emerald according to the respective IFU and without device related deficiencies.

Trial Locations

Locations (8)

Klinikum Wels Grieskirchen; 🇦🇹 Wels, Austria

VZW Jessa Ziekenhus; 🇧🇪 Hasselt, Belgium

Kepler Universitätsklinikum GmbH; 🇦🇹 Linz, Austria

Ordensklinikum Linz GmbH; 🇦🇹 Linz, Austria

ST. Poelten; 🇦🇹 St. Poelten, Austria

AZ Sint Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

Klinik Floridsdorf; 🇦🇹 Wien, Austria

Klinik Favoriten; 🇦🇹 Wien, Austria