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OpenTrials
Active, Not Recruiting

NCT Number: NCT05788432

Sequent Extended Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de Araba, Alava, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SeQuent Please Neo

Device

Patients in whom treatment with (Sequent Please Neo) has been attempted

Primary outcomes

  1. Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)

    Time frame: 12 months

    Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)

Secondary outcomes

  1. Freedom from MACE in the subgroup of Lesions In-stent Restenosis

    Time frame: 12 months

    Freedom from MACE in the subgroup of Lesions In-stent Restenosis

  2. Freedom from MACE in the subgroup of Native vessel lesions

    Time frame: 12 months

    Freedom from MACE in the subgroup of Native vessel lesions

  3. Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches

    Time frame: 12 months

    Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches

  4. Procedural success

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

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

Acronym: rEpic06

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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