Clinical trial
Essential Pro Post-Market Clinical Follow-up Study
Name
Essential Pro PMCF Study
Description
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.
Trial arms
Trial start
2022-09-26
Estimated PCD
2025-02-02
Trial end
2025-03-30
Status
Recruiting
Treatment
Essential pro
Patients in whom treatment with (Essential Pro) has been attempted
Arms:
Coronary Artery Disease (CAD)
Size
176
Primary endpoint
Safety Endpoint. Freedom from Target Lesion Failure
12 months
Eligibility criteria
Inclusion Criteria:
* Patient treated with Essential Pro according to routine hospital practice and following instructions for use
* Informed consent signed
Exclusion Criteria:
• Not meet inclusion criteria
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 176, 'type': 'ESTIMATED'}}
Updated at
2024-01-31
1 organization
1 product
2 indications
Organization
Fundación EPICProduct
Essential proIndication
coronary artery diseaseIndication
Ischaemic Heart Disease