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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Diabetes
• Interventions: Device: device implantation during coronary angioplasty

• Registration Number: NCT03399994
• Lead Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

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.

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-17
• Study Start: 2018-05-21
• Primary Completion: 2021-04-15
• Status Verified: 2022-03
• Study Completion: 2022-07-26
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABLUMINUS DES+	device implantation during coronary angioplasty	device implantation during coronary angioplasty
Everolimus-eluting DES	device implantation during coronary angioplasty	device implantation during coronary angioplasty

Primary Outcome Measures

Name	Time	Method
In-stent neointimal volume	9-month follow-up	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

Name	Time	Method
Lesion success	24 hours	Attainment of \<50% residual stenosis of the target lesion using post-PCI
Neointimal area	9-month follow-up	Neointimal area, calculated at the site of minimal lumen area measured with OCT.
Stent thrombosis	12 months	This is defined according to classification proposed by the Academic Research Consortium
Cardiac death	12 months	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.
Device success at 24 hours	24 hours	deployment of the assigned stents without system failure or device-related complication
Target Lesion Failure	12 months	This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR
Target vessel myocardial infarction	12 months	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	12 months	repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI.
Procedural success	24 hours	Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay

Trial Locations

Locations (6)

Ospedale Humanitas; 🇮🇹 Rozzano, Milano, Italy

Policlinico S. Matteo; 🇮🇹 Pavia, Italy

Ospedale San Raffaele; 🇮🇹 Miano, Milano, Italy

Azienda Ospedaliero Universitaria Policlinico Federico II; 🇮🇹 Napoli, Italy

Policlinico San Donato; 🇮🇹 San Donato Milanese, Milano, Italy

Ospedale San Pietro, Fatebenefratelli; 🇮🇹 Roma, Italy