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

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Status: Enrolling

Conditions: Coronary Artery Disease; Coronary Artery Stenosis

Treatments: Device: Everolimus Eluting Stent; Device: Sirolimus Coated Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT04893291

TRANSFORM II

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,820 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,820 participants in 2 patient groups

Everolimus Eluting Stent

Active Comparator group

Treatment:

Device: Everolimus Eluting Stent

Magic Touch Sirolimus Coated Balloon

Experimental group

Treatment:

Device: Sirolimus Coated Balloon

Sponsor of this trial

Lead Sponsor

Fondazione Ricerca e Innovazione Cardiovascolare ETS