Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Paclitaxel eluting coronary balloon dilatation catheter
Brief summary
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
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.
Interventions
DEVICESequent Please Neo
Patients in whom treatment with (Sequent Please Neo) has been attempted
Sponsors
Fundación EPIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events) | 12 months | Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from MACE in the subgroup of Lesions In-stent Restenosis | 12 months | Freedom from MACE in the subgroup of Lesions In-stent Restenosis |
| Freedom from MACE in the subgroup of Native vessel lesions | 12 months | Freedom from MACE in the subgroup of Native vessel lesions |
| Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches | 12 months | Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches |
| Procedural success | Immediately after PCI (Percutaneous Coronary Intervention) | Procedural success ( Residual stenosis \<30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure) |
Countries
Spain
Outcome results
None listed