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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2028
  • participants needed
    1325
  • sponsor
    Fondazione Ricerca e Innovazione Cardiovascolare ETS
Updated on 15 June 2022
angiography
sirolimus
everolimus
percutaneous coronary intervention

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).

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 mm of diameter (by visual estimation) will be enrolled in this study.

Details
Condition Coronary Artery Disease, Coronary Artery Stenosis
Treatment Sirolimus coated balloon, Everolimus Eluting Stent
Clinical Study IdentifierNCT04893291
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS
Last Modified on15 June 2022

Eligibility

Yes No Not Sure

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 ≦3.0 mm at visual estimation
maximum lesion length: 40 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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