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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399994
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : March 29, 2022
Sponsor:
Collaborator:
Mediolanum Cardio Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Device: device implantation during coronary angioplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized multi-centre controlled clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
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
Actual Study Start Date : May 21, 2018
Actual Primary Completion Date : April 15, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Everolimus

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




Primary Outcome Measures :
  1. In-stent neointimal volume [ Time Frame: 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 :
  1. Neointimal area [ Time Frame: 9-month follow-up ]
    Neointimal area, calculated at the site of minimal lumen area measured with OCT.

  2. Target Lesion Failure [ Time Frame: 12 months ]
    This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR

  3. Stent thrombosis [ Time Frame: 12 months ]
    This is defined according to classification proposed by the Academic Research Consortium

  4. Cardiac death [ Time Frame: 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.

  5. Target vessel myocardial infarction [ Time Frame: 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

  6. Target lesion revascularization [ Time Frame: 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.

  7. Device success at 24 hours [ Time Frame: 24 hours ]
    deployment of the assigned stents without system failure or device-related complication

  8. Lesion success [ Time Frame: 24 hours ]
    Attainment of <50% residual stenosis of the target lesion using post-PCI

  9. Procedural success [ Time Frame: 24 hours ]
    Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399994


Locations
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Italy
Ospedale San Raffaele
Miano, Milano, Italy, 20132
Ospedale Humanitas
Rozzano, Milano, Italy, 20089
Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
Azienda Ospedaliero Universitaria Policlinico Federico II
Napoli, Italy, 20131
Policlinico S. Matteo
Pavia, Italy, 27100
Ospedale San Pietro, Fatebenefratelli
Roma, Italy, 00189
Sponsors and Collaborators
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Mediolanum Cardio Research
Investigators
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Study Director: Antonio Colombo, MD Ospedale San Raffaele
Principal Investigator: Azeem Latib, MD Ospedale San Raffaele
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Responsible Party: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
ClinicalTrials.gov Identifier: NCT03399994    
Other Study ID Numbers: ABILITY
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases