Sequent Extended Study

Recruiting

• Conditions: Ischemic Heart Disease; Coronary Artery Disease

• Registration Number: NCT05788432
• Lead Sponsor: Fundación 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.

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-26
• Study Start: 2023-03-28
• Study First Posted: 2023-03-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-23
• Primary Completion: 2026-06-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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 (26)

Hospital Universitario de Araba; 🇪🇸 Alava, Spain

Hospital General Universitario de Alicante Dr.Balmis; 🇪🇸 Alicante, Spain

Hospital Universitario de Badajoz; 🇪🇸 Badajoz, Spain

Hospital Universitari Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hospital Universitario de Cruces; 🇪🇸 Baracaldo, Spain

Hospital de La Santa Creu Y Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Puerta Del Mar; 🇪🇸 Cadiz, Spain

Hospital General Universitari de Castelló; 🇪🇸 Castelló, Spain

Hospital Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

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