Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II (NCT04893291) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II
Bangladesh1,820 participantsStarted 2021-11-16
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of target Lesion Failure (TLF) at 12 Months
Timeframe: 12 Months
2
Number of NACEs
Timeframe: 12 Months
Trial details
NCT IDNCT04893291
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS