Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT03399994
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2018-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES
Sponsor:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: