Sequent Extended Study

Study Overview
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Brief Summary
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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.

Detailed Description
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The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.

Official Title
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Sequent Please Neo Extended Post-Market Clinical Follow-up Study

Conditions
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Coronary Artery Disease, Ischemic Heart Disease

Intervention / Treatment
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* Device: Sequent Please Neo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with Sequent please neo according to routine hospital practice and following instruction for use. Informed Consent Signed. Exclusion Criteria: Patient life expectancy less than 12 months. Contraindication for antiplatelet therapy. Not meet inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease (CAD)<br> | Device: Sequent Please Neo<br>* Patients in whom treatment with (Sequent Please Neo) has been attempted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events) | Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from MACE in the subgroup of Lesions In-stent Restenosis | Freedom from MACE in the subgroup of Lesions In-stent Restenosis | 12 months | 
| Freedom from MACE in the subgroup of Native vessel lesions | Freedom from MACE in the subgroup of Native vessel lesions | 12 months | 
| Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches | Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches | 12 months | 
| Procedural success | Procedural success ( Residual stenosis <30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure) | Immediately after PCI (Percutaneous Coronary Intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Paclitaxel eluting coronary balloon dilatation catheter