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Active, not recruiting Not applicable

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

NCT04893291 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-11-16
Last updated
2026-02-19

Condition(s) studied

Coronary Artery DiseaseCoronary Artery Stenosis

Investigational drug(s) / intervention(s)

Everolimus Eluting StentSirolimus Coated Balloon

Everolimus Eluting Stent: Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care

Sirolimus Coated Balloon: Patients assigned to this Arm will be treated with Magic Touch Drug Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (53)

FacilityCityRegionStatus
Bangladesh Specialized Hospital Lt Dhaka Bangladesh
Kurmitola General Hospital Dhaka Bangladesh
LABAID Cardiac Hospital Dhaka Bangladesh
National Heart Foundation Hospital & Research Institute Dhaka Bangladesh
National Institute of Cardiovascular Disease Dhaka Bangladesh
Hospital de Clínicas de Porto Alegre Porto Alegre Brazil
INC (National Institute of Cardiology), Rio de Janeiro Brazil
InCor (Heart Institute) São Paulo Brazil
Institute Dante Pazzanese of Cardiology São Paulo Brazil
Hospital Santa Isabel R. Frei Cornélio Ubá Brazil
Jurong Park Medical Centre JPMC Bandar Seri Begawan Brunei
Clinique Louis Pasteur Essey-lès-Nancy France
Groupe Hospitalier de La Rochelle La Rochelle France
Les Hôpitaux de Chartres, Hôpital Louis Pasteur Le Coudray France
Hôpital Prive du Confluent, 4 Rue Éric Tabarly Nantes France
Clinique Saint-Hilaire Rouen France
Centre Hospitalier de SaintMalo St-Malo France
Ospedale San Giuseppe Moscati Aversa Italy
Fondazione Poliambulanza Brescia Italy
Ospedale Policlinico San Martino Genova Italy
Ospedale Civile Sant'Andrea La Spezia Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Istituto clinico Sant'Ambrogio Milan Italy
Clinica Polispecialistica San Carlo Paderno Dugnano Italy
A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli Palermo Italy
Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello" Palermo Italy
Ospedale Sandro Pertini Roma Italy
Azienda Ospedaliero-Universitaria Sant'Andrea Roma Italy
Policlinico Tor Vergata Roma Italy
Ospedale S. Antonio Abate Trapani Italy
Azienda Ospedaliera Universitaria Integrata Verona Italy
Hospital Queen Elizabeth II Kota Kinabalu Malaysia
University Malaya Medical Centre (Teaching and Research Hospital) Kuala Lumpur Malaysia
OLVG Onze Lieve Vrouwe Gasthuis location East Amsterdam Netherlands
Albert Schweitzer Hospital Dordrecht Netherlands
Erasmus University Medical Center Rotterdam Netherlands
Maasstad Hospital Rotterdam Netherlands
Haga Hospital Els Borst The Hague Netherlands
1st Military Institute of Medicine Lublin Poland
Heliodors Święcicki Clinical Univeristy Hospital, Ul Poznan Poland

+ 13 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04893291 on ClinicalTrials.gov ↗ ← All trials in Italy