Coronary Artery Disease, Coronary Artery Stenosis
Conditions
Keywords
DCB, EES, Optical Coherence Tomography (OCT), Sirolimus, Everolimus, TLF
Brief summary
International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).
Detailed description
The purpose of TRANSFORM II study is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting Drug Eluting Stent (DES). Given the inherent and recognized limitations of stents in native vessels with diameter \<3 mm, only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) will be enrolled in this study.
Interventions
DEVICEEverolimus Eluting Stent
Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care
DEVICESirolimus Coated Balloon
Patients assigned to this Arm will be treated with Magic Touch Drug Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care
Sponsors
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years; * all patients with a clinical indication to Percutaneous Coronary Intervention (PCI) (stable coronary artery disease or acute coronary syndromes); * native coronary artery lesion in a vessel with diameter \>2.0 mm and ≦3.5 mm at visual estimation; * maximum lesion length: 50 mm. * informed consent to participate in the study.
Exclusion criteria
* patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated; * patients participating in another clinical study; * subject is a woman who is pregnant or nursing (pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception); * creatinine clearance \<30 ml/min; * left ventricular ejection fraction \<30%; * life expectancy \<12 months; * ST-elevation myocardial infarction in the previous 48 hours; * visible thrombus at lesion site; * culprit lesion stenosis \>99% and/or Thrombolysis In Myocardial Infarction (TIMI) flow \<2; * target lesion/vessel with any of the following characteristics: * concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary artery); * pre-dilatation of the target lesion not performed or not successful (residual stenosis \>30%); * severe calcification of the target vessel, at lesion site but also proximally; * highly tortuous vessel which could impair device delivery to the lesion site following Investigator's judgement; * previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery); * bifurcation lesion where side branch treatment is anticipated; * left main stem stenosis \>50%; * target lesion is in left main stem * Lesion is located within asaphenous vein graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of target Lesion Failure (TLF) at 12 Months | 12 Months | Non-inferiority of Magic Touch SCB compared to everolimus-eluting DES (EES) in terms of target lesion failure (TLF), a composite clinical endpoint, at 12 months. |
| Number of NACEs | 12 Months | Verify the superiority of the study device in terms of net adverse clinical events (NACE), a composite endpoint including all-cause death, myocardial infarction (MI), ischemic stroke, and major bleedings following the Bleeding Academic Research Consortium (BARC) types 3 or 5 definition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 6, 12, 24, 36, 48 and 60 months | The occurrence of cardiac death |
| Death of any cause; | 6, 12, 24, 36, 48 and 60 months | The occurrence of death of any cause; |
| Q-wave MI | 6, 12, 24, 36, 48 and 60 months | The occurrence of Q-wave MI; |
| MI | 6, 12, 24, 36, 48 and 60 months | The occurrence of any MI; |
| Target Lesion Revascularization (TLR) | 6, 12, 24, 36, 48 and 60 months | The occurrence of TLR; |
| Target Vessel Revascularization (TVR) | 6, 12, 24, 36, 48 and 60 months | The occurrence of target vessel revascularization |
| Bleeding | 6, 12, 24, 36, 48 and 60 months | The occurrence of bleedings following the BARC classification |
Countries
Bangladesh, Brazil, Brunei, France, Italy, Malaysia, Netherlands, Poland, Spain, Thailand, United Kingdom
Outcome results
None listed