Sequent Extended Study
- Conditions
- Ischemic Heart DiseaseCoronary Artery Disease
- Interventions
- Device: Sequent Please Neo
- Registration Number
- NCT05788432
- Lead Sponsor
- Fundaci贸n EPIC
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
- Informed Consent Signed.
- Patient life expectancy less than 12 months.
- Contraindication for antiplatelet therapy.
- Not meet inclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Coronary Artery Disease (CAD) Sequent Please Neo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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-stent Restenosis 12 months Freedom from MACE in the subgroup of Lesions In-stent Restenosis
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)
Trial Locations
- Locations (23)
Hospital de La Santa Creu Y Sant Pau
馃嚜馃嚫Barcelona, Spain
Hospital Universitario de Araba
馃嚜馃嚫Alava, Spain
Hospital General Universitario de Alicante Dr.Balmis
馃嚜馃嚫Alicante, Spain
Hospital Universitario de Badajoz
馃嚜馃嚫Badajoz, Spain
Hospital Universitari Germans Trias I Pujol
馃嚜馃嚫Badalona, Spain
Hospital Universitario de Cruces
馃嚜馃嚫Baracaldo, Spain
Hospital Clinic de Barcelona
馃嚜馃嚫Barcelona, Spain
Hospital Universitario Puerta Del Mar
馃嚜馃嚫Cadiz, Spain
Hospital Universitario de Ciudad Real
馃嚜馃嚫Ciudad Real, Spain
Hospital Universitario San Pedro de Alcantara
馃嚜馃嚫C谩ceres, Spain
Hospital General Universitario de Elche
馃嚜馃嚫Elche, Spain
Hospital Universitari Dr. Josep Trueta
馃嚜馃嚫Gerona, Spain
Hospital Universitario Juan Ramon Jimenez
馃嚜馃嚫Huelva, Spain
Hospital Universitario de Jaen
馃嚜馃嚫Ja茅n, Spain
Hospital Universitario de Leon
馃嚜馃嚫Le贸n, Spain
Hospital Universitario Lucus Agusti
馃嚜馃嚫Lugo, Spain
Hospital Universitario de La Princesa
馃嚜馃嚫Madrid, Spain
Hospital Universitario 12 de Octubre
馃嚜馃嚫Madrid, Spain
Hospital Universitario Virgen de La Victoria
馃嚜馃嚫Malaga, Spain
Hospital Regional Universitario de Malaga
馃嚜馃嚫M谩laga, Spain
Hospital de M茅rida
馃嚜馃嚫M茅rida, Spain
Hospital Clinico Universitario de Salamanca
馃嚜馃嚫Salamanca, Spain
Hospital Universitario Virgen Del Rocio
馃嚜馃嚫Sevilla, Spain