Personalized Vs. Standard Duration of Dual Antiplatelet Therapy and New-generation Polymer-Free vs- Biodegradable-Polymer DES (PARTHENOPE)
Coronary Artery Disease, Acute Coronary Syndrome, Chronic Coronary Syndrome
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years;
- Clinical evidence of coronary artery disease requiring PCI with DES implantation;
- Any coronary lesion sized 2.25-4.5 mm by visual estimation.
Exclusion Criteria:
- Inability to provide informed consent;
- Active bleeding requiring medical attention (BARC ≥2);
- Need for chronic oral anticoagulant therapy;
- Planned surgery within 3 months;
- Known hypersensitivity or allergy to aspirin or any P2Y12 receptor inhibitor (clopidogrel, prasugrel, ticagrelor), heparin, contrast agent, or any DES-components;
- Previous treatment with bioresorbable vascular scaffolds;
- Participation in another study that has not reached the primary endpoint;
- A life expectancy of less than 24 months;
- Female of childbearing potential;
- Under judicial protection, tutorship or curatorship.
Sites / Locations
- Casa di Cura Villa Dei Fiori
- Ospedale S.Maria delle Grazie
- Ospedale "Maria SS. Addolorata"
- A.O.R.N. S.Giuseppe Moscati-Città Ospedaliera
- Ospedale San Giuseppe Moscati
- A.O.R.N. Sant'Anna e San Sebastiano
- Ospedale San Giuliano
- Federico II University of Naples
- A.O.R.N. A. Cardarelli
- Ospedale San Giovanni Bosco - ASL Napoli 1
- Ospedale del Mare
- Ospedale Santa Maria della Pietà
- AOU San Giovanni di Dio e Ruggi d'Aragona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Cre8 AES and personalized DAPT duration
Cre8 AES and standard DAPT duration
Synergy EES and personalized DAPT duration
Synergy EES and standard DAPT duration
Percutaneous coronary intervention with implantation of a Cre8 amphilimus- eluting stent for coronary artery disease. Personalized duration of dual antiplatelet therapy for 3-, 6-, or 24-month after percutaneous coronary intervention based on the DAPT score.
Percutaneous coronary intervention with implantation of a Cre8 amphilimus- eluting stent for coronary artery disease. Standard duration of dual antiplatelet therapy for 12-month after percutaneous coronary intervention.
Percutaneous coronary intervention with implantation of a Synergy everolimus-eluting stent for coronary artery disease. Personalized duration of dual antiplatelet therapy for 3-, 6-, or 24-month after percutaneous coronary intervention based on the DAPT score.
Percutaneous coronary intervention with implantation of a Synergy everolimus-eluting stent for coronary artery disease. Standard duration of dual antiplatelet therapy for 12-month after percutaneous coronary intervention.