Health TrialsbyHealthPanel

Sequent Extended Study

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

About this trial

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.

Informed Consent Signed.

Disqualifiers

Patient life expectancy less than 12 months.

Contraindication for antiplatelet therapy.

Not meet inclusion criteria.

Trial population

Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sequent Please Neo

    Device

    Patients in whom treatment with (Sequent Please Neo) has been attempted

Treatment groups

2,028 Participants
are divided into 1 treatment group
Group A: Coronary Artery Disease (CAD)1 intervention

Trial outcomes

Primary outcomes

1

Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)

Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)

Time frame
12 months

Secondary outcomes

1

Freedom from MACE in the subgroup of Lesions In-stent Restenosis

Freedom from MACE in the subgroup of Lesions In-stent Restenosis

Time frame
12 months
2

Freedom from MACE in the subgroup of Native vessel lesions

Freedom from MACE in the subgroup of Native vessel lesions

Time frame
12 months
3

Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches

Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches

Time frame
12 months
4

Procedural success

Procedural success ( Residual stenosis \<30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure)

Time frame
Immediately after PCI (Percutaneous Coronary Intervention)

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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