NCT03399994

Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES

A Randomized Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES for Percutaneous Coronary Intervention in Patients With Diabetes Mellitus: an Investigator-initiated Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 on Late Lumen Loss and clinical outcomes in diabetic patients undergoing Percutaneous Coronary Intervention. A total of 165 patients will be recruited and randomized in the two groups in a 2:1 ratio at up to 6-8 Italian sites. After index procedure, patients will be followed up by angiographic follow-up at 9 months and clinical follow-up at 12 months. The study design is open label, since it is not possible to blind the investigators as to the stent type. However the members of the Event Adjudication Committee will be blinded to the patient. assignment. All medical records, source documentation and event information collected for the adjudication process will be blinded to treatment assignment. In addition the primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment.

Conditions

• Coronary Artery Disease
• Diabetes

Interventions

Type	Name	Description
DEVICE	device implantation during coronary angioplasty	device implantation during coronary angioplasty

Timeline

• Start date: 2018-05-21
• Primary completion: 2021-04-15
• Completion: 2022-07-26
• First posted: 2018-01-17
• Last updated: 2022-07-27

Locations

6 sites across 1 country: Italy