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

N/AActive Not RecruitingNCT04893291

Fondazione Ricerca e Innovazione Cardiovascolare ETS1,820 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,820

Conditions

Coronary Artery Disease Coronary Artery Stenosis

Interventions

Everolimus Eluting StentDEVICE

Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care

Sirolimus Coated BalloonDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (53)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 Months