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

The objective of the study is to compare angiographic and clinical performance of Abluminus DES+ versus Everolimus-eluting DES in patients with diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Diabetes
• Intervention / Treatment: Device: device implantation during coronary angioplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 20131
    • Azienda Ospedaliero Universitaria Policlinico Federico II
  • Pavia, Italy, 27100
    • Policlinico S. Matteo
  • Roma, Italy, 00189
    • Ospedale San Pietro, Fatebenefratelli
  • Milano
    • Miano, Milano, Italy, 20132
      • Ospedale San Raffaele
    • Rozzano, Milano, Italy, 20089
      • Ospedale Humanitas
    • San Donato Milanese, Milano, Italy, 20097
      • Policlinico San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age>18
2. Diabetes mellitus
3. Documented CAD: stable or unstable angina, Non-ST segment MI, silent ischemia or positive functional study
4. PCI considered appropriate and feasible
5. 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);
6. Patient provides written informed consent
7. Patient agrees to all required follow-up procedures and visits.
8. Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm.

Exclusion Criteria:

1. 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);
2. Any contraindication to the implant of the Abluminus DES+
3. 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;;
4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
5. Previous coronary intervention on target vessel in the 3-months prior to enrollment;
6. Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
7. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
8. Previously documented left ventricular ejection fraction (LVEF) <30%;
9. Evident cardiogenic shock before randomization;
10. Patients with left main stem stenosis (>50% by visual estimate);
11. In-stent restenosis;
12. ST-segment elevation MI;
13. Chronic total occlusion.
14. Culprit lesion to a Saphenous Vein graft

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABLUMINUS DES+; device implantation during coronary angioplasty	Device: device implantation during coronary angioplasty; device implantation during coronary angioplasty
Active Comparator: Everolimus-eluting DES; device implantation during coronary angioplasty	Device: device implantation during coronary angioplasty; device implantation during coronary angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neointimal area	Neointimal area, calculated at the site of minimal lumen area measured with OCT.	9-month follow-up
Target Lesion Failure	This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR	12 months
Stent thrombosis	This is defined according to classification proposed by the Academic Research Consortium	12 months
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.	12 months
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	12 months
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.	12 months
Device success at 24 hours	deployment of the assigned stents without system failure or device-related complication	24 hours
Lesion success	Attainment of <50% residual stenosis of the target lesion using post-PCI	24 hours
Procedural success	Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay	24 hours

Collaborators and Investigators

• Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
• Collaborators: Mediolanum Cardio Research
• Investigators: Study Director: Antonio Colombo, MD, Ospedale San Raffaele; Principal Investigator: Azeem Latib, MD, Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ABILITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No