Clinical trial NCT03399994: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Diabetes
Lead sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Sponsor class: OTHER
Collaborators: name: Mediolanum Cardio Research
First posted: 2018-01-17
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized multi-centre controlled clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-stent neointimal volume
timeFrame: 9-month follow-up
Secondary outcomes:
measure: Neointimal area
timeFrame: 9-month follow-up
measure: Target Lesion Failure
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Target vessel myocardial infarction
timeFrame: 12 months
measure: Target lesion revascularization
timeFrame: 12 months
measure: Device success at 24 hours
timeFrame: 24 hours
measure: Lesion success
timeFrame: 24 hours
measure: Procedural success
timeFrame: 24 hours
Other outcomes:
Locations:
city: Miano
country: Italy
facility: Ospedale San Raffaele
state: Milano
city: Rozzano
country: Italy
facility: Ospedale Humanitas
state: Milano
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
state: Milano
city: Napoli
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Federico II
city: Pavia
country: Italy
facility: Policlinico S. Matteo
city: Roma
country: Italy
facility: Ospedale San Pietro, Fatebenefratelli
Study officials:
affiliation: Ospedale San Raffaele
name: Antonio Colombo, MD
role: STUDY_DIRECTOR
affiliation: Ospedale San Raffaele
name: Azeem Latib, MD
role: PRINCIPAL_INVESTIGATOR
References: