Status:
ACTIVE_NOT_RECRUITING
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
Lead Sponsor:
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Conditions:
Coronary Artery Disease
Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
1820 Patients enrolled
Trial Details
Trial ID
NCT04893291
Start Date
November 16 2021
End Date
August 30 2030
Last Update
December 30 2025
Active Locations (53)
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1
Bangladesh Specialized Hospital Lt
Dhaka, Bangladesh
2
Kurmitola General Hospital
Dhaka, Bangladesh
3
LABAID Cardiac Hospital
Dhaka, Bangladesh
4
National Heart Foundation Hospital & Research Institute
Dhaka, Bangladesh