Status:
COMPLETED
Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES
Lead Sponsor:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Collaborating Sponsors:
Mediolanum Cardio Research
Conditions:
Coronary Artery Disease
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to compare angiographic and clinical performance of Abluminus DES+ versus Everolimus-eluting DES in patients with diabetes mellitus.
Detailed Description
The present clinical investigation is designed as a prospective, multicentre, national, randomized, open label, 2-arm parallel group, pilot trial comparing Abluminus DES+ versus Everolimus-eluting DES...
Eligibility Criteria
Inclusion
- Age\>18
- Diabetes mellitus
- Documented CAD: stable or unstable angina, Non-ST segment MI, silent ischemia or positive functional study
- PCI considered appropriate and feasible
- Culprit de novo lesion in a native coronary artery with significant stenosis (\>50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length);
- Patient provides written informed consent
- Patient agrees to all required follow-up procedures and visits.
- Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm.
Exclusion
- The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus, everolimus, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled);
- Any contraindication to the implant of the Abluminus DES+
- Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use effective methods of contraception;;
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
- Previous coronary intervention on target vessel in the 3-months prior to enrollment;
- Non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- Previously documented left ventricular ejection fraction (LVEF) \<30%;
- Evident cardiogenic shock before randomization;
- Patients with left main stem stenosis (\>50% by visual estimate);
- In-stent restenosis;
- ST-segment elevation MI;
- Chronic total occlusion.
- Culprit lesion to a Saphenous Vein graft
Key Trial Info
Start Date :
May 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2022
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03399994
Start Date
May 21 2018
End Date
July 26 2022
Last Update
July 27 2022
Active Locations (6)
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1
Ospedale San Raffaele
Miano, Milano, Italy, 20132
2
Ospedale Humanitas
Rozzano, Milano, Italy, 20089
3
Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
4
Azienda Ospedaliero Universitaria Policlinico Federico II
Napoli, Italy, 20131