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

May 11, 2023 updated by: Fondazione Ricerca e Innovazione Cardiovascolare ETS
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1820

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Recruiting
        • National Heart Foundation Hospital & Research Institute
        • Contact:
          • Fazila Malik
  • France
      • Essey-lès-Nancy, France
        • Recruiting
        • Clinique Louis Pasteur
        • Contact:
          • Julien Lemoine
      • La Rochelle, France
        • Recruiting
        • Groupe Hospitalier de La Rochelle
        • Contact:
          • Ludovic Meunier
      • Saint-Malo, France
        • Recruiting
        • Centre Hospitalier de SaintMalo
        • Contact:
          • Mourad Mejri
  • Italy
      • Aversa, Italy
        • Recruiting
        • Ospedale San Giuseppe Moscati
        • Contact:
          • Gianluca Caiazzo
      • Brescia, Italy, 25124
        • Recruiting
        • Fondazione Poliambulanza
        • Principal Investigator:
          • Diego Maffeo
        • Contact:
          • Diego Maffeo
      • Genova, Italy
        • Recruiting
        • Ospedale Policlinico San Martino
        • Contact:
          • Matteo Vercellino
        • Principal Investigator:
          • Matteo Vercellino
      • La Spezia, Italy
        • Recruiting
        • Ospedale Civile Sant'Andrea
        • Contact:
          • Alberto Menozzi
        • Principal Investigator:
          • Alberto Menozzi
      • Milano, Italy
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Irene Bossi
        • Principal Investigator:
          • Irene Bossi
      • Milano, Italy
        • Recruiting
        • Istituto Clinico Sant'Ambrogio
        • Contact:
          • Alfonso Ielasi
        • Principal Investigator:
          • Alfonso Ielasi
      • Paderno Dugnano, Italy, 20037
        • Recruiting
        • Clinica Polispecialistica San Carlo
        • Contact:
          • Guido Belli
        • Principal Investigator:
          • Guido Belli
      • Roma, Italy, 00157
        • Recruiting
        • Ospedale Sandro Pertini
        • Contact:
          • Alessandro Sciahbasi
        • Principal Investigator:
          • Alessandro Sciahbasi
      • Roma, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Sant'Andrea
        • Contact:
          • Stefano Rigattieri
        • Principal Investigator:
          • Stefano Rigattieri
      • Roma, Italy
        • Recruiting
        • Policlinico Tor Vergata
        • Contact:
          • Giuseppe Sangiorgi
        • Principal Investigator:
          • Giuseppe Sangiorgi
      • Trapani, Italy
        • Recruiting
        • Ospedale S. Antonio Abate
        • Contact:
          • Dario Buccheri
        • Principal Investigator:
          • Dario Buccheri
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • OLVG Onze Lieve Vrouwe Gasthuis location East
        • Contact:
          • Vink M.A
      • Dordrecht, Netherlands
        • Recruiting
        • Albert Schweitzer Hospital
        • Contact:
          • Rohit Oemrawsingh
      • Leeuwarden, Netherlands
        • Recruiting
        • Medical Center Leeuwarden
        • Contact:
          • Sjoerd Hofma
      • Rotterdam, Netherlands
        • Recruiting
        • Maasstad Hospital
        • Contact:
          • Valeria Paradies
  • Spain
      • Ciudad Real, Spain
        • Recruiting
        • Hospital General Universitario de Ciudad Real (HGUCR)
        • Contact:
          • Ignacio Sanchez-Perez
      • Gasteiz / Vitoria, Spain
        • Recruiting
        • Hospital Universitario de Araba
        • Contact:
          • Alfonso Torres-Bosco
      • Lugo, Spain
        • Recruiting
        • Hospital Universitario Lucus Augusti (HULA)
        • Contact:
          • Raymundo Ocaranza Sánchez
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Raul Moreno Gómez
      • Madrid, Spain
        • Recruiting
        • Hospital de La Princesa
        • Contact:
          • Fernando Alfonso
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla (HUMV)
        • Contact:
          • José María de la Torre Hernández

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months
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.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 6, 12, 24, 36, 48 and 60 months
The occurrence of cardiac death
6, 12, 24, 36, 48 and 60 months
Death of any cause;
Time Frame: 6, 12, 24, 36, 48 and 60 months
The occurrence of death of any cause;
6, 12, 24, 36, 48 and 60 months
Q-wave MI
Time Frame: 6, 12, 24, 36, 48 and 60 months
The occurrence of Q-wave MI;
6, 12, 24, 36, 48 and 60 months
MI
Time Frame: 6, 12, 24, 36, 48 and 60 months
The occurrence of any MI;
6, 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
Time Frame: 6, 12, 24, 36, 48 and 60 months
The occurrence of TLR;
6, 12, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR)
Time Frame: 6, 12, 24, 36, 48 and 60 months
The occurrence of target vessel revascularization
6, 12, 24, 36, 48 and 60 months
Bleeding
Time Frame: 6, 12, 24, 36, 48 and 60 months
The occurrence of bleedings following the BARC classification
6, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2021

Primary Completion (Anticipated)

November 30, 2024

Study Completion (Anticipated)

November 30, 2028

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRANSFORM II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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