Health Trials

Coroflex® ISAR NEO PMCF Study

ConditionsCoronary Artery Disease (CAD)Ischemic Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be at least 18 years of age AND

The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND

Patients with Novo lesion length 2-4 mm AND

Informed consent signed

Disqualifiers

Patients with express refusal by the patient to participate in the study.

Patients pregnant women and lactating women.

Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).

Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated

Trial population

Patients treated with Coroflex® ISAR NEO coronary stent system according to routine hospital practice and following instructions for use

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Coroflex® ISAR NEO coronary stent system

    Device

    Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: Coronary Artery Disease (CAD) and high risk of bleeding1 intervention
Group B: 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, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR)

Time frame
7 days
2

Efficacy Endpoint. Freedom fromTarget Lesion Failure

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

Time frame
7 days

Secondary outcomes

1

Freedom from Accidental dislodgement of the stent

Freedom from Accidental dislodgement of the stent

Time frame
During percutaneous coronary intervention (PCI)
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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