Clinical trial NCT04893291: Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
Official title: Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Keywords: DCB
EES
Optical Coherence Tomography (OCT)
Sirolimus
Everolimus
TLF
Lead sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 1820
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of target Lesion Failure (TLF) at 12 Months
timeFrame: 12 Months
measure: Number of NACEs
timeFrame: 12 Months
Secondary outcomes:
measure: Cardiac death
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Death of any cause;
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Q-wave MI
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: MI
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Bleeding
timeFrame: 6, 12, 24, 36, 48 and 60 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: National Heart Foundation Hospital & Research Institute
city: Essey-lès-Nancy
country: France
facility: Clinique Louis Pasteur
city: La Rochelle
country: France
facility: Groupe Hospitalier de La Rochelle
city: Saint-Malo
country: France
facility: Centre Hospitalier de SaintMalo
city: Aversa
country: Italy
facility: Ospedale San Giuseppe Moscati
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: La Spezia
country: Italy
facility: Ospedale Civile Sant'Andrea
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Milano
country: Italy
facility: Istituto clinico Sant'Ambrogio
city: Paderno Dugnano
country: Italy
facility: Clinica Polispecialistica San Carlo
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Trapani
country: Italy
facility: Ospedale S. Antonio Abate
city: Amsterdam
country: Netherlands
facility: OLVG Onze Lieve Vrouwe Gasthuis location East
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real (HGUCR)
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario de Araba
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti (HULA)
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla (HUMV)
Study officials:
References:
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