Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

Conditions
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Coronary Artery Disease, Coronary Artery Stenosis

Intervention / Treatment
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* Device: Everolimus Eluting Stent
* Device: Sirolimus Coated Balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Everolimus Eluting Stent<br> | Device: Everolimus Eluting Stent<br>* Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care<br>|
| Experimental: Magic Touch Sirolimus Coated Balloon<br> | Device: Sirolimus Coated Balloon<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of target Lesion Failure (TLF) at 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. | 12 Months | 
| Number of NACEs | 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. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death | The occurrence of cardiac death | 6, 12, 24, 36, 48 and 60 months | 
| Death of any cause; | The occurrence of death of any cause; | 6, 12, 24, 36, 48 and 60 months | 
| Q-wave MI | The occurrence of Q-wave MI; | 6, 12, 24, 36, 48 and 60 months | 
| MI | The occurrence of any MI; | 6, 12, 24, 36, 48 and 60 months | 
| Target Lesion Revascularization (TLR) | The occurrence of TLR; | 6, 12, 24, 36, 48 and 60 months | 
| Target Vessel Revascularization (TVR) | The occurrence of target vessel revascularization | 6, 12, 24, 36, 48 and 60 months | 
| Bleeding | The occurrence of bleedings following the BARC classification | 6, 12, 24, 36, 48 and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCB, EES, Optical Coherence Tomography (OCT), Sirolimus, Everolimus, TLF