An interventional study of IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon) and Taxus (Paclitaxel eluting stent) in Coronary Artery Disease, sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-14.
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 112th largest by enrollment of the 189 interventional ones that give a count, is one of 11 that started in 2010, is one of 81 with no phase, and was the 48th 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. 11 started in 2010.
This study's enrollment of 182 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.
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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:
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Prospective multicentre randomized (1:1) investigator initiated study, in which consecutive patients undergoing percutaneous revascularization of small coronary vessels will be assigned to one of the two study arms:
Eligible subjects with coronary artery disease in a small vessel (reference diameter\<2.8mm) will be consecutively screened and enrolled based on the inclusion and exclusion criteria
The objective of the study is to assess the non-inferiority of the DEB to the PES as regards to primary endpoint of mean late lumen loss (LLL) at 6 months, defined as the difference between postprocedural minimum luminal (MLD) diameter and follow-up MLD, as assessed by quantitative coronary angiography and is based on the following assumptions:
Based on these assumptions:
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.
Angiographic Inclusion Criteria:
Exclusion Criteria:
Angiographic 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent).
Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.
Device: Taxus (Paclitaxel eluting stent)
Coronary Artery Bypass Graft (CABG)
Also known as: IN.PACT Falcon paclitaxel eluting balloon
Percutaneous transluminal coronary angioplasty (PTCA) with stent
Late Lumen Loss (LLL) at 6 months follow-up defined as the difference between postprocedural minimum luminal diameter and follow-up minimum luminal diameter, as assessed by quantitative coronary angiography
Time frame: 6 Month
Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion.
Time frame: day 1
Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization
Time frame: day 1
MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure
Time frame: 30 days, 6 months,1, 2, 3 years
Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure
Time frame: 6 months,1, 2, 3 years
Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure
Time frame: 6 months,1, 2, 3 years
Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year
Time frame: 1 Year
Binary Restenosis rate at 6 months follow-up
Time frame: 6 months
The record gives a start of Mar 2010, a primary completion of Mar 2012 and a completion of May 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS