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
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|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Ischemic Heart Disease||Device: Sequent Please Neo|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
|Coronary Artery Disease (CAD)||
Device: Sequent Please Neo
Patients in whom treatment with (Sequent Please Neo) has been attempted
- 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)
- 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
- Freedom from MACE in the subgroup of Native vessel lesions [ Time Frame: 12 months ]Freedom from MACE in the subgroup of Native vessel lesions
- 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
- 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)
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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|
- 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.
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
|Contact: ORIOL RODRIGUEZ LEOR, MD, PhDfirstname.lastname@example.org|
|Contact: FUNDACION EPICemail@example.com|
|Responsible Party:||Fundación EPIC|
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
MDR (Medical Device Regulations)
PMCF (Post-Market Clinical Follow-up)
Paclitaxel eluting coronary balloon dilatation catheter
Coronary Artery Disease
Arterial Occlusive Diseases