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Coronary Artery DiseaseNCT03399994

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

A study testing device implantation during coronary angioplasty in people with Coronary Artery Disease and Diabetes, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 6 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Diabetes
What is being tested?
device implantation during coronary angioplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
6 sitesItaly
Study dates
21 May 2018to 26 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 14Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • Ospedale San Raffaele

    Miano, Milano, 20132

  • Azienda Ospedaliero Universitaria Policlinico Federico II

    Naples, 20131

  • Policlinico S. Matteo

    Pavia, 27100

  • Ospedale San Pietro, Fatebenefratelli

    Roma, 00189

  • Ospedale Humanitas

    Rozzano, Milano, 20089

  • Policlinico San Donato

    San Donato Milanese, Milano, 20097

Other trials in Italy

About this study

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

The objective of the study is to compare angiographic and clinical performance of Abluminus DES+ versus Everolimus-eluting DES in patients with diabetes mellitus.

Read the 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.

Being tested
device implantation during coronary angioplasty
Medical subject headings
Coronary Artery Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • device implantation during coronary angioplastyDevice

    device implantation during coronary angioplasty

Study groups in NCT03399994
Study groupRoleWhat they receive
ABLUMINUS DES+Experimentaldevice implantation during coronary angioplasty
Receives: Device: device implantation during coronary angioplasty
Everolimus-eluting DESActive comparatordevice implantation during coronary angioplasty
Receives: Device: device implantation during coronary angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9-month follow-up

Secondary outcomes (9)

  1. Neointimal area

    Neointimal area, calculated at the site of minimal lumen area measured with OCT.

    Measured: 9-month follow-up

  2. Target Lesion Failure

    This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR

    Measured: 12 months

  3. Stent thrombosis

    This is defined according to classification proposed by the Academic Research Consortium

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. Device success at 24 hours

    deployment of the assigned stents without system failure or device-related complication

    Measured: 24 hours

  8. Lesion success

    Attainment of <50% residual stenosis of the target lesion using post-PCI

    Measured: 24 hours

  9. Procedural success

    Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start21 May 2018
  3. Primary completion15 Apr 2021
  4. Study completion26 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized multi-centre controlled clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03399994
Sponsor's protocol ID
ABILITY
Status last verified
Mar 2022
First submitted
9 Jan 2018
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing device implantation during coronary angioplasty in people with Coronary Artery Disease and Diabetes, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent neointimal volume (time frame: 9-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03399994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.

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