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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04893291
Recruitment Status : Recruiting
First Posted : May 19, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Fondazione Ricerca e Innovazione Cardiovascolare ETS

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Stenosis Device: Everolimus Eluting Stent Device: Sirolimus Coated Balloon Not Applicable

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 mm of diameter (by visual estimation) will be enrolled in this study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Everolimus Eluting Stent Device: 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
Experimental: Magic Touch Sirolimus Coated Balloon Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of target Lesion Failure (TLF) at 12 Months [ Time Frame: 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.

  2. Number of NACEs [ Time Frame: 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 :
  1. Cardiac death [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    The occurrence of cardiac death

  2. Death of any cause; [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    The occurrence of death of any cause;

  3. Q-wave MI [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    The occurrence of Q-wave MI;

  4. MI [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    The occurrence of any MI;

  5. Target Lesion Revascularization (TLR) [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    The occurrence of TLR;

  6. Target Vessel Revascularization (TVR) [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    The occurrence of target vessel revascularization

  7. Bleeding [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    The occurrence of bleedings following the BARC classification


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≦3.0 mm at visual estimation;
  • maximum lesion length: 40 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04893291


Contacts
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Contact: Bernardo Cortese, Dr. +39 348 1123968 bcortese@gmail.com

Locations
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Italy
Fondazione Poliambulanza Recruiting
Brescia, Italy, 25124
Contact: Diego Maffeo         
Principal Investigator: Diego Maffeo         
Clinica Polispecialistica San Carlo Recruiting
Paderno Dugnano, Italy, 20037
Contact: Bernardo Cortese       bcortese@gmail.com   
Principal Investigator: Bernardo Cortese         
Ospedale Sandro Pertini Recruiting
Roma, Italy, 00157
Contact: Alessandro Sciahbasi         
Principal Investigator: Alessandro Sciahbasi         
Sponsors and Collaborators
Fondazione Ricerca e Innovazione Cardiovascolare ETS
More Information
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Publications:

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Responsible Party: Fondazione Ricerca e Innovazione Cardiovascolare ETS
ClinicalTrials.gov Identifier: NCT04893291    
Other Study ID Numbers: TRANSFORM II
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Ricerca e Innovazione Cardiovascolare ETS:
DCB
EES
Optical Coherence Tomography (OCT)
 Sirolimus
Everolimus
TLF
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
 Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents