Back to resultsClinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES
Primary Purpose
Coronary Artery Disease, Diabetes
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
device implantation during coronary angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Ospedale San Raffaele
- Ospedale Humanitas
- Policlinico San Donato
- Azienda Ospedaliero Universitaria Policlinico Federico II
- Policlinico S. Matteo
- Ospedale San Pietro, Fatebenefratelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABLUMINUS DES+
Everolimus-eluting DES
Arm Description
device implantation during coronary angioplasty
device implantation during coronary angioplasty
Outcomes
Primary Outcome Measures
In-stent neointimal volume
In-stent neointimal volume, measured with OCT, following PCI with Abluminus DES+ compared with in-stent neointimal volume following PCI with Everolimus-eluting DES.
Secondary Outcome Measures
Neointimal area
Neointimal area, calculated at the site of minimal lumen area measured with OCT.
Target Lesion Failure
This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR
Stent thrombosis
This is defined according to classification proposed by the Academic Research Consortium
Cardiac death
Any death due to proximate cardiac cause (eg, MI, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
Target vessel myocardial infarction
Any MI that, irrespective of the time after the index procedure, is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause33 Type of acute MI is classified according to the Joint ESC/ACCF/AHA/ WHF Joint Task Force for the Universal Definition of Myocardial Infarction
Target lesion revascularization
repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI.
Device success at 24 hours
deployment of the assigned stents without system failure or device-related complication
Lesion success
Attainment of <50% residual stenosis of the target lesion using post-PCI
Procedural success
Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay
Full Information
NCT ID
NCT03399994
First Posted
January 9, 2018
Last Updated
July 26, 2022
Sponsor
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Collaborators
Mediolanum Cardio Research
1. Study Identification
Unique Protocol Identification Number
NCT03399994
Brief Title
Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
July 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Collaborators
Mediolanum Cardio Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized multi-centre controlled clinical trial
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABLUMINUS DES+
Arm Type
Experimental
Arm Description
device implantation during coronary angioplasty
Arm Title
Everolimus-eluting DES
Arm Type
Active Comparator
Arm Description
device implantation during coronary angioplasty
Intervention Type
Device
Intervention Name(s)
device implantation during coronary angioplasty
Intervention Description
device implantation during coronary angioplasty
Primary Outcome Measure Information:
Title
In-stent neointimal volume
Description
In-stent neointimal volume, measured with OCT, following PCI with Abluminus DES+ compared with in-stent neointimal volume following PCI with Everolimus-eluting DES.
Time Frame
9-month follow-up
Secondary Outcome Measure Information:
Title
Neointimal area
Description
Neointimal area, calculated at the site of minimal lumen area measured with OCT.
Time Frame
9-month follow-up
Title
Target Lesion Failure
Description
This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR
Time Frame
12 months
Title
Stent thrombosis
Description
This is defined according to classification proposed by the Academic Research Consortium
Time Frame
12 months
Title
Cardiac death
Description
Any death due to proximate cardiac cause (eg, MI, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
Time Frame
12 months
Title
Target vessel myocardial infarction
Description
Any MI that, irrespective of the time after the index procedure, is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause33 Type of acute MI is classified according to the Joint ESC/ACCF/AHA/ WHF Joint Task Force for the Universal Definition of Myocardial Infarction
Time Frame
12 months
Title
Target lesion revascularization
Description
repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI.
Time Frame
12 months
Title
Device success at 24 hours
Description
deployment of the assigned stents without system failure or device-related complication
Time Frame
24 hours
Title
Lesion success
Description
Attainment of <50% residual stenosis of the target lesion using post-PCI
Time Frame
24 hours
Title
Procedural success
Description
Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Colombo, MD
Organizational Affiliation
Ospedale San Raffaele
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Azeem Latib, MD
Organizational Affiliation
Ospedale San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Raffaele
City
Miano
State/Province
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Federico II
City
Napoli
ZIP/Postal Code
20131
Country
Italy
Facility Name
Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale San Pietro, Fatebenefratelli
City
Roma
ZIP/Postal Code
00189
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES
We'll reach out to this number within 24 hrs