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Sequent Extended Study (rEpic06)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05788432
Recruitment Status : Not yet recruiting
First Posted : March 28, 2023
Last Update Posted : March 28, 2023
Sponsor:
Information provided by (Responsible Party):
Fundación EPIC

Study Description
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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.

Condition or disease Intervention/treatment
Coronary Artery Disease Ischemic Heart Disease Device: 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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sequent Please Neo Extended Post-Market Clinical Follow-up Study
Estimated Study Start Date : March 30, 2023
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Coronary Artery Disease (CAD) Device: Sequent Please Neo
Patients in whom treatment with (Sequent Please Neo) has been attempted


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05788432


Contacts
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Contact: ORIOL RODRIGUEZ LEOR, MD, PhD 0034934651200 oriolrodriguez@gmail.com
Contact: FUNDACION EPIC 0034987876135 iepic@fundacionepic.org

Sponsors and Collaborators
Fundación EPIC
More Information
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Publications:

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Responsible Party: Fundación EPIC
ClinicalTrials.gov Identifier: NCT05788432    
Other Study ID Numbers: rEpic06- SEQUENT EXTENDED
First Posted: March 28, 2023    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación EPIC:
MDR (Medical Device Regulations)
PMCF (Post-Market Clinical Follow-up)
Paclitaxel eluting coronary balloon dilatation catheter
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases