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PMCF Study for Cardiology Access Procedures

NCT05543096 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-07-28

No results posted yet for this study

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

Interventions

DEVICE

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

Observation

Sponsors & Collaborators

  • FCRE (Foundation for Cardiovascular Research and Education)

    collaborator OTHER

  • Cordis Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2022-08-31
Completion
2022-09-07

Countries

  • Austria
  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543096 on ClinicalTrials.gov