PRISTINE RegistryProspective, multI-centric, Single arm post marketing surveillance of PRISTINE, Everolimus Eluting Cobalt Chromium Coronary Stent System to assess its continued safety and efficacy - PreQuest-01

Relisys Medical Devices Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1.Male or non-pregnant female: at least 18 years of age
•2.Undergone PCI for de-novo coronary lesions for stable angina / acute coronary syndrome (STEMI, N-STEMI, Unstable angina) with PRISTINE DES
•3.Patient agrees to comply with specified follow-up evaluations at the site
•4.Patient or LAR providing written informed consent
•5.Patient is willing to come back for follow-up evaluations including OCT after 9 months – in selected patients

•1. Patients presented with heart failure (Killips class 3 and 4 during hospitalization)
•2. Renal failure with eGFR < 60
•3. Any other chronic organ / system disease (Chronic hepatic / pulmonary etc.)
•4. CVA within last 12 months
•5. Chronic total occlusion, Bifurcation lesion with significant side branch, lesion in bypass graft
•6. Prior stenting in the target vessel
•7. Patient has a life expectancy < 12 months
•8. Target vessel diameter below 2.5mm
•9. Patient is a recipient of a heart transplant
•10. Prior history of significant bleeding (within the previous 6 months) that might preclude use of dual antiplatelet therapy.
•11. Pregnant or nursing woman or who wants to become pregnant in near future
•12. Known allergies or hypersensitivity to Clopidogrel bisulfate, Cobalt Chromium alloy, Everolimus and and contrast media that cannot be medically managed.
•13. Total length of overlapping stents in a single vessel more than 60mm
•14. In the investigator opinion, any significant medical condition which may interfere with the patients optimal participation in this study
•15. Intervention of another coronary lesion has occurred within 90 days before or is planned within 90 days after the index procedure.
•16. Patient who has participated in other trial whose primary end-point is yet to be met.

发起方

Relisys Medical Devices Limited