Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases+3
+ Coronary Disease
+ Heart Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: March 6, 2023
Actual date on which the first participant was enrolled.The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Conditions
Pathology
Criteria
Inclusion Criteria: Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP): * Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication * Patient \>18 years * Patient who understands the trial requirements and the treatment procedures and provides written informed consent Exclusion Criteria: Patients will be excluded as per IFU, Hospital standard of care and GCP. Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location