An interventional study of device implantation during coronary angioplasty in Coronary Artery Disease and Diabetes, sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS. Completed at 6 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Not applicable, Interventional, and Treatment
Among 302 studies in Coronary Artery Disease with a site in Italy — 48 open to participants now, 71 under way, 7 of them phase 3. Coronary Artery Disease · Italy.
Among the 302 studies in Coronary Artery Disease with a site in Italy, this one is the 131st largest by enrollment of the 189 interventional ones that give a count, is one of 14 that started in 2018, is one of 81 with no phase, and was the 170th registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
Browse Coronary Artery Disease studies →48 of the 302 studies in Coronary Artery Disease with a site in Italy are open now. Recruiting first, the newest first:
Centro Cardiologico Monzino · Sites in Italy
IRCCS San Raffaele · Sites in Italy
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Sites in Italy
Centro Cardiologico Monzino · Sites in Italy
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Sites in Italy, Poland, Romania and 1 more country
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
302 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 13 · Phase 3 41 · Phase 4 57
First in 2000; this study’s year is marked. 14 started in 2018.
This study's enrollment of 137 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Median enrollment 290 across the 189 interventional studies, 400 across the 113 observational. Of the 151 that completed or were terminated, 35 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
101 of 302 have an industry lead sponsor. The 10 most frequent:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS has 3 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
12 of the studies in Coronary Artery Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06410690Centro Cardiologico MonzinoTrustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS | 2026-11-30 |
| NCT04604782GE HealthcareA Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients | 2026-12 |
| NCT06321757Fundación EPICPREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients | 2026-12-30 |
| NCT07817524Fondazione Policlinico Universitario Agostino Gemelli IRCCSClinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN) | 2026-12-31 |
| NCT07291609Azienda Ospedaliera "Sant'Andrea"Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes | 2026-12-31 |
Among the 302 studies in Coronary Artery Disease with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The objective of the study is to compare angiographic and clinical performance of Abluminus DES+ versus Everolimus-eluting DES in patients with diabetes mellitus.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
device implantation during coronary angioplasty
Device: device implantation during coronary angioplasty
device implantation during coronary angioplasty
Device: device implantation during coronary angioplasty
device implantation during coronary angioplasty
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.
Time frame: 9-month follow-up
Neointimal area
Neointimal area, calculated at the site of minimal lumen area measured with OCT.
Time frame: 9-month follow-up
Target Lesion Failure
This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR
Time frame: 12 months
Stent thrombosis
This is defined according to classification proposed by the Academic Research Consortium
Time frame: 12 months
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.
Time frame: 12 months
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
Time frame: 12 months
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.
Time frame: 12 months
Device success at 24 hours
deployment of the assigned stents without system failure or device-related complication
Time frame: 24 hours
Lesion success
Attainment of \<50% residual stenosis of the target lesion using post-PCI
Time frame: 24 hours
Procedural success
Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Apr 2021, 34 months.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's 34 months is close to that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS