An interventional study of Magic Touch SCB by Concept Medical Inc. in Coronary Restenosis, sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS. Completed at 7 sites in Italy. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Not applicable, Interventional, and Treatment
Among 15 studies in Coronary Restenosis with a site in Italy — 1 open to participants now, 2 under way, none of them phase 3. Coronary Restenosis · Italy.
Among the 15 studies in Coronary Restenosis with a site in Italy, this one is the 11th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2023, is one of 3 with no phase, and was the 15th registered.
107 studies on the registry are indexed under Coronary Restenosis; 10 are open to participants now.
Browse Coronary Restenosis studies →1 of the 15 studies in Coronary Restenosis with a site in Italy is open now. Recruiting first, the newest first:
Abbott Medical Devices · Sites in Italy, United States, Australia and 11 more countries
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 8 Coronary Restenosis studies recruiting now, 7 (88%) set no upper age limit and 1 (13%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 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.
15 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2023.
This study's enrollment of 110 is below the median of 242 across 69 interventional studies indexed under Coronary Restenosis.
Median enrollment 324 across the 11 interventional studies, 549 across the 4 observational. Of the 12 that completed or were terminated, 4 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 15 have an industry lead sponsor. The 6 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 1 study filed under Coronary Restenosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Coronary Restenosis with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Evaluate angiographic performance in long lesions of Sirolimus Eluting Balloon Magic Touch by Concept Medical
To assess the angiographic performance of the Magic Touch Sirolimus-Coated Balloon (SCB) at 9 months follow-up after PCI for de novo CAD.
Primary end-points:
Secondary end-points:
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.
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.
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.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QCA at 9 months
Device: Magic Touch SCB by Concept Medical Inc.
PCI with drug-coated balloon
late lumen loss at 9 months measured by quantitative coronary angiography
QCA by core lab
Time frame: 18 months
incidence of adverse clinical events
myocardial infarction, death, need for revascularization
Time frame: 18 months
Plan to share: No — upon request
Ran from May 2023 to primary completion in Oct 2025, 28 months.
Of 13 interventional studies with no phase under Coronary Restenosis, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 61. This study's 28 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS