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

NCT03399994 | Completed DMC

• 1 other identifier: ABILITY
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Artery Disease; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Neointimal area

  9-month follow-up

• Target Lesion Failure

  12 months

• Stent thrombosis

  12 months

• Cardiac death

  12 months

• Target vessel myocardial infarction

  12 months

Study Arms (2)

ABLUMINUS DES+

EXPERIMENTAL

device implantation during coronary angioplasty

Device: device implantation during coronary angioplasty

Everolimus-eluting DES

ACTIVE COMPARATOR

device implantation during coronary angioplasty

Device: device implantation during coronary angioplasty

Interventions

device implantation during coronary angioplasty DEVICE

device implantation during coronary angioplasty

ABLUMINUS DES+; Everolimus-eluting DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS: lead
• Mediolanum Cardio Research: collaborator

Study Sites (6)

Ospedale San Raffaele

Miano, Milano, 20132, Italy

Location

Ospedale Humanitas

Rozzano, Milano, 20089, Italy

Location

Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Federico II

Napoli, 20131, Italy

Location

Policlinico S. Matteo

Pavia, 27100, Italy

Location

Ospedale San Pietro, Fatebenefratelli

Roma, 00189, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Antonio Colombo, MD

  Ospedale San Raffaele

  STUDY DIRECTOR

• Azeem Latib, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized multi-centre controlled clinical trial

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: May 21, 2018
• Primary Completion: April 15, 2021
• Study Completion: July 26, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)