Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II
Overview
- Phase
- N/A
- Intervention
- Everolimus Eluting Stent
- Conditions
- Coronary Artery Disease
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Enrollment
- 1820
- Locations
- 53
- Primary Endpoint
- Number of target Lesion Failure (TLF) at 12 Months
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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:
Arms & Interventions
Everolimus Eluting Stent
Intervention: Everolimus Eluting Stent
Magic Touch Sirolimus Coated Balloon
Intervention: Sirolimus Coated Balloon
Outcomes
Primary Outcomes
Number of target Lesion Failure (TLF) at 12 Months
Time Frame: 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
Time Frame: 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 Outcomes
- Bleeding(6, 12, 24, 36, 48 and 60 months)
- MI(6, 12, 24, 36, 48 and 60 months)
- Cardiac death(6, 12, 24, 36, 48 and 60 months)
- Death of any cause;(6, 12, 24, 36, 48 and 60 months)
- Q-wave MI(6, 12, 24, 36, 48 and 60 months)
- Target Lesion Revascularization (TLR)(6, 12, 24, 36, 48 and 60 months)
- Target Vessel Revascularization (TVR)(6, 12, 24, 36, 48 and 60 months)