Health TrialsbyHealthPanel

Essential Pro Study ( rEPIC04E-HK )

ConditionsCoronary Artery DiseaseIschemic Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

Single center, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient treated with Essential Pro according to routine hospital practice and following instructions for use

Informed consent signed

Disqualifiers

Not meet inclusion criteria

Trial population

Patients treated with Essential Pro according to routine hospital practice and following instructions for use

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Essential pro

    Device

    Patients in whom treatment with (Essential Pro) has been attempted

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Coronary Artery Disease (CAD)1 intervention

Trial outcomes

Primary outcomes

1

Safety Endpoint. Freedom from Target Lesion Failure

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR). Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).

Time frame
12 months

Secondary outcomes

1

Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

Time frame
12 months
2

Freedom from Balloon rupture

Freedom from Balloon rupture

Time frame
During PCI
3

Freedom from Hypotube rupture

Freedom from Hypotube rupture

Time frame
During PCI
4

Freedom from Complicated withdrawal

Freedom from Complicated withdrawal

Time frame
During PCI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
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