Sequent Extended Study (rEpic06)

Fundación EPIC

Status: Enrolling

Conditions: Ischemic Heart Disease; Coronary Artery Disease

Treatments: Device: Sequent Please Neo

Study type: Observational

Funder types: Other

Identifiers

NCT05788432

rEpic06- SEQUENT EXTENDED

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,028 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,028 participants in 1 patient group

Coronary Artery Disease (CAD)

Treatment:

Device: Sequent Please Neo