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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399994
• Other study ID #: ABILITY
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: July 26, 2022

Study information

• Verified date: March 2022
• Source: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 26, 2022
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes

Intervention

Device:
• device implantation during coronary angioplasty
device implantation during coronary angioplasty

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Miano	Milano
Italy	Azienda Ospedaliero Universitaria Policlinico Federico II	Napoli
Italy	Policlinico S. Matteo	Pavia
Italy	Ospedale San Pietro, Fatebenefratelli	Roma
Italy	Ospedale Humanitas	Rozzano	Milano
Italy	Policlinico San Donato	San Donato Milanese	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS	Mediolanum Cardio Research

Country where clinical trial is conducted

Italy, 

Outcome

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