PMCF Study for Cardiology Access Procedures

NCT05543096 | Completed

• 1 other identifier: FCRE-220111_Cardio
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 8

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.

Conditions

Coronary Artery Disease

Keywords

Cardiology

Outcome Measures

Primary Outcomes (16)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  30 days post procedure

Secondary Outcomes (9)

• Secondary Efficacy Endpoint: Successful crossing, introduction and deployment

  30 days post procedure

• Secondary Efficacy Endpoint: Successful crossing, introduction and deployment

  30 days post procedure

• Secondary Efficacy Endpoint: Successful crossing, introduction and deployment

  30 days post procedure

• Secondary Efficacy Endpoint: Successful crossing, introduction and deployment

  30 days post procedure

• Secondary Efficacy Endpoint: Successful crossing, introduction and deployment

  30 days post procedure

Interventions

Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires DEVICE

Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diseased patients with CAD who underwent a PCI within standard-of-care (SOC) of the coronary arterial vessel. In this PMCF minimally invasive medical devices will be used. Indications for which the study devices are intended are listed in section 3.1. Patients will be selected based on the investigator's assessment and evaluation of the underlying disease retrospective. The patient's medical condition should have been stable, with no underlying medical condition which would prevent them from undergoing the required endovascular intervention at the time of procedure. The total sample size for this PMCF study is 200 patients, divided over up to 20 sites, throughout an enrolment period of 6 months.

You may qualify if:

• Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for percutaneous coronary intervention (PCI).
• Patient is \>18 years old at the conduction of the procedure.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cordis US Corp.: lead
• FCRE (Foundation for Cardiovascular Research and Education): collaborator

Study Sites (8)

Kepler Universitätsklinikum GmbH

Linz, Austria

Location

Ordensklinikum Linz GmbH

Linz, Austria

Location

ST. Poelten

Sankt Pölten, Austria

Location

Klinik Favoriten

Vienna, Austria

Location

Klinik Floridsdorf

Vienna, Austria

Location

Klinikum Wels Grieskirchen

Wels, Austria

Location

VZW Jessa Ziekenhus

Hasselt, Belgium

Location

AZ Sint Nikolaas

Sint-Niklaas, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: September 16, 2022
• Study Start: May 23, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 7, 2022
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

BE (2); AU (6)