Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
- Conditions
- Coronary Artery DiseaseCoronary Artery Stenosis
- Interventions
- Device: Sirolimus Coated BalloonDevice: Everolimus Eluting Stent
- Registration Number
- NCT04893291
- Lead Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- 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 to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1820
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Magic Touch Sirolimus Coated Balloon Sirolimus Coated Balloon - Everolimus Eluting Stent Everolimus Eluting Stent -
- Primary Outcome Measures
Name Time Method Number of target Lesion Failure (TLF) at 12 Months 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.
Number of NACEs 12 Months 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.
- Secondary Outcome Measures
Name Time Method Bleeding 6, 12, 24, 36, 48 and 60 months The occurrence of bleedings following the BARC classification
Cardiac death 6, 12, 24, 36, 48 and 60 months The occurrence of cardiac death
MI 6, 12, 24, 36, 48 and 60 months The occurrence of any MI;
Death of any cause; 6, 12, 24, 36, 48 and 60 months The occurrence of death of any cause;
Q-wave MI 6, 12, 24, 36, 48 and 60 months The occurrence of Q-wave MI;
Target Lesion Revascularization (TLR) 6, 12, 24, 36, 48 and 60 months The occurrence of TLR;
Target Vessel Revascularization (TVR) 6, 12, 24, 36, 48 and 60 months The occurrence of target vessel revascularization
Trial Locations
- Locations (25)
National Heart Foundation Hospital & Research Institute
🇧🇩Dhaka, Bangladesh
Clinique Louis Pasteur
🇫🇷Essey-lès-Nancy, France
Groupe Hospitalier de La Rochelle
🇫🇷La Rochelle, France
Centre Hospitalier de SaintMalo
🇫🇷Saint-Malo, France
Ospedale San Giuseppe Moscati
🇮🇹Aversa, Italy
Fondazione Poliambulanza
🇮🇹Brescia, Italy
Ospedale Civile Sant'Andrea
🇮🇹La Spezia, Italy
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Ospedale Sandro Pertini
🇮🇹Roma, Italy
Istituto clinico Sant'Ambrogio
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
🇮🇹Roma, Italy
Ospedale S. Antonio Abate
🇮🇹Trapani, Italy
OLVG Onze Lieve Vrouwe Gasthuis location East
🇳🇱Amsterdam, Netherlands
Policlinico Tor Vergata
🇮🇹Roma, Italy
Albert Schweitzer Hospital
🇳🇱Dordrecht, Netherlands
Medical Center Leeuwarden
🇳🇱Leeuwarden, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
Hospital Universitario de Araba
🇪🇸Gasteiz / Vitoria, Spain
Hospital General Universitario de Ciudad Real (HGUCR)
🇪🇸Ciudad Real, Spain
Hospital Universitario Lucus Augusti (HULA)
🇪🇸Lugo, Spain
Hospital de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Marqués de Valdecilla (HUMV)
🇪🇸Santander, Spain
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Clinica Polispecialistica San Carlo
🇮🇹Paderno Dugnano, Italy