Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03085823 |
| Other study ID # |
fbf001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2016 |
| Est. completion date |
January 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Fatebenefratelli and Ophthalmic Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The purpose of this study is to observe and evaluate the performance of a Sirolimus-eluting
Drug Coated Balloon for the treatment of any type of coronary lesions, including native
vessel disease and in stent restenosis.
Description:
The drug coated balloons (DCB) are one of the most promising innovations in the
interventional cardiology field, and in some cases represent a valid alternative to stents.
The numerous devices currently on the market, and the clinical results sometimes encouraging,
sometimes less, have clearly shown that there is no "class" effect. The DCB so far available
were conformed to elute only paclitaxel, an high lipophilicity drug with a narrow therapeutic
window, cytotoxic at medium-high dosage.
The DCB allow the drug release without needing to implant prostheses in the coronary vessel;
such prostheses (stents have been shown to be associated with an increased risk of thrombotic
events, even years after implantation, caused by a non- healing of the vessel by the action
of the drug itself or of the polymer, together with the presence of the metal of the stent .
After a DCP angioplasty the absence of such implants, instead, ensures a quick recovery of
the vessel function. Moreover, the absence of the prosthesis is particularly favorable in the
case of small/medium diameter vessels, tortuous or severe calcific vessel, or for the
treatment of in-stent restenosis.
In the Bello study, the DCB IN.PACT Falcon, has reached the non-inferiority expected (and
also the superiority, not expected), against the same DES regarding the primary endpoint of
late lumen loss (LLL) at the angiographic control. The results of this study, encouraging for
the drug-eluting balloon technology, however, are tainted by a now obsolete technology, the
use of an endpoint that supports the balloon (LLL), and the comparison with a DES that is no
longer in trade and is objectively inferior to those used in 2016.
Several new generation DCB have been developed in the last years, with the aim of improving
the paclitaxel release in the coronary wall, thus reducing the risk of restenosis. In
addition, several improvements have involved the trackability and deliverability of these
devices even in tortuous and small vessels . The latest generation DCB have several
advantages compared to the old generation DCB: paclitaxel is layered with an inert support
(matrix or carrier) using a multi-layer technology, improving both its release and the
persistence in the vessel wall; furthermore, significant improvements have been made to
address the poor deliverability of first generation balloons.
In 2016 the Magic Touch, a new type of DCB has obtained, first, the CE mark for marketing in
Europe; it is characterized by eluting sirolimus, a drug with potent inhibitory effect on
cell growth, but with low lipophilicity. For this reason, its ability to penetrate the wall
of the vessel is limited, and so far it has not been possible to develop a device that would
allow an effective release, despite the drug is now known for years in cardiology.
The purpose of this study is to evaluate the DCB Magic Touch performance in terms of efficacy
and safety when used during coronary angioplasty, in a wide spectrum of coronary heart
disease.
The primary objective of the study is to verify the rate of target vessel revascularization
(TLR) at 12 months after implantation, both with new coronary angioplasty or coronary artery
bypass graft.
Secondary objectives will be:
- angiographic success, defined as residual stenosis < 50% and TIMI 3 coronary flow; -
procedural success, defined as angiographic success and absence of adverse
cardiovascular events during initial hospitalization;
- major adverse cardiac events (MACE ), a composite endpoint of cardiac death, acute
myocardial infarction and need for TLR at 6, 12 and 24 months of implantation;
- every single element determining the MACE endpoint. This is a multicenter, prospective,
spontaneous, observational, single-arm, clinical study, where will be enrolled patients
with coronary artery disease and clinical indication for coronary angioplasty.
The indication for coronary angioplasty will be stable angina pectoris, silent ischemia or
acute coronary syndrome (unstable angina or acute myocardial infarction).
Before participating all subjects will be informed about the study, including the possible
risks and benefit, and will be asked to provide a written informed consent. Subjects will be
instructed that may not meet the general criteria for inclusion or those angiographic, or
that could satisfy at least one criterion for exclusion and therefore be excluded from the
study (screening failure), even after informed consent.
