Status:
ACTIVE_NOT_RECRUITING
Personalized Vs. Standard Duration of Dual Antiplatelet Therapy and New-generation Polymer-Free vs- Biodegradable-Polymer DES
Lead Sponsor:
Federico II University
Collaborating Sponsors:
AdvicePharma Group
Conditions:
Coronary Artery Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
New-generation metallic drug-eluting stents represent the standard of care among patients undergoing percutaneous coronary intervention (PCI). Currently, few data are available as regards to the safet...
Detailed Description
The objective of the trial is: i) to evaluate the efficacy and safety of the Cre8 AES vs. the Synergy EES in a broadly unselected patient population with coronary artery disease undergoing PCI; ii) t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 24 2024
Estimated Enrollment :
2106 Patients enrolled
Trial Details
Trial ID
NCT04135989
Start Date
January 1 2020
End Date
October 24 2024
Last Update
February 23 2024
Active Locations (13)
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1
Casa di Cura Villa Dei Fiori
Acerra, Naples, Italy, 80011
2
Ospedale S.Maria delle Grazie
Pozzuoli, Naples, Italy, 80078
3
Ospedale "Maria SS. Addolorata"
Eboli, SA, Italy, 84025
4
A.O.R.N. S.Giuseppe Moscati-Città Ospedaliera
Avellino, Italy, 83100