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

Primary Purpose

Coronary Artery Disease, Coronary Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Everolimus Eluting Stent
Sirolimus Coated Balloon
Sponsored by
Fondazione Ricerca e Innovazione Cardiovascolare ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring DCB, EES, Optical Coherence Tomography (OCT), Sirolimus, Everolimus, TLF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Heart Foundation Hospital & Research InstituteRecruiting
  • Clinique Louis PasteurRecruiting
  • Groupe Hospitalier de La RochelleRecruiting
  • Centre Hospitalier de SaintMaloRecruiting
  • Ospedale San Giuseppe MoscatiRecruiting
  • Fondazione PoliambulanzaRecruiting
  • Ospedale Policlinico San MartinoRecruiting
  • Ospedale Civile Sant'AndreaRecruiting
  • ASST Grande Ospedale Metropolitano NiguardaRecruiting
  • Istituto clinico Sant'AmbrogioRecruiting
  • Clinica Polispecialistica San CarloRecruiting
  • Ospedale Sandro PertiniRecruiting
  • Azienda Ospedaliero-Universitaria Sant'AndreaRecruiting
  • Policlinico Tor VergataRecruiting
  • Ospedale S. Antonio AbateRecruiting
  • OLVG Onze Lieve Vrouwe Gasthuis location EastRecruiting
  • Albert Schweitzer HospitalRecruiting
  • Medical Center LeeuwardenRecruiting
  • Maasstad HospitalRecruiting
  • Hospital General Universitario de Ciudad Real (HGUCR)Recruiting
  • Hospital Universitario de ArabaRecruiting
  • Hospital Universitario Lucus Augusti (HULA)Recruiting
  • Hospital de La PrincesaRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Marqués de Valdecilla (HUMV)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Everolimus Eluting Stent

Magic Touch Sirolimus Coated Balloon

Arm Description

Outcomes

Primary Outcome Measures

Number of target Lesion Failure (TLF) at 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
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

Cardiac death
The occurrence of cardiac death
Death of any cause;
The occurrence of death of any cause;
Q-wave MI
The occurrence of Q-wave MI;
MI
The occurrence of any MI;
Target Lesion Revascularization (TLR)
The occurrence of TLR;
Target Vessel Revascularization (TVR)
The occurrence of target vessel revascularization
Bleeding
The occurrence of bleedings following the BARC classification

Full Information

First Posted
May 13, 2021
Last Updated
May 11, 2023
Sponsor
Fondazione Ricerca e Innovazione Cardiovascolare ETS
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1. Study Identification

Unique Protocol Identification Number
NCT04893291
Brief Title
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
Acronym
TRANSFORM II
Official Title
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Ricerca e Innovazione Cardiovascolare ETS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Stenosis
Keywords
DCB, EES, Optical Coherence Tomography (OCT), Sirolimus, Everolimus, TLF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1820 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Everolimus Eluting Stent
Arm Type
Active Comparator
Arm Title
Magic Touch Sirolimus Coated Balloon
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Everolimus Eluting Stent
Intervention Description
Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care
Intervention Type
Device
Intervention Name(s)
Sirolimus Coated Balloon
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of target Lesion Failure (TLF) at 12 Months
Description
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.
Time Frame
12 Months
Title
Number of NACEs
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Cardiac death
Description
The occurrence of cardiac death
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Death of any cause;
Description
The occurrence of death of any cause;
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Q-wave MI
Description
The occurrence of Q-wave MI;
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
MI
Description
The occurrence of any MI;
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Target Lesion Revascularization (TLR)
Description
The occurrence of TLR;
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Target Vessel Revascularization (TVR)
Description
The occurrence of target vessel revascularization
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Bleeding
Description
The occurrence of bleedings following the BARC classification
Time Frame
6, 12, 24, 36, 48 and 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernardo Cortese, Dr.
Phone
+39 348 1123968
Email
bcortese@gmail.com
Facility Information:
Facility Name
National Heart Foundation Hospital & Research Institute
City
Dhaka
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fazila Malik
Facility Name
Clinique Louis Pasteur
City
Essey-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Lemoine
Facility Name
Groupe Hospitalier de La Rochelle
City
La Rochelle
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovic Meunier
Facility Name
Centre Hospitalier de SaintMalo
City
Saint-Malo
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mourad Mejri
Facility Name
Ospedale San Giuseppe Moscati
City
Aversa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianluca Caiazzo
Facility Name
Fondazione Poliambulanza
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Maffeo
First Name & Middle Initial & Last Name & Degree
Diego Maffeo
Facility Name
Ospedale Policlinico San Martino
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Vercellino
First Name & Middle Initial & Last Name & Degree
Matteo Vercellino
Facility Name
Ospedale Civile Sant'Andrea
City
La Spezia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Menozzi
First Name & Middle Initial & Last Name & Degree
Alberto Menozzi
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Bossi
First Name & Middle Initial & Last Name & Degree
Irene Bossi
Facility Name
Istituto clinico Sant'Ambrogio
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Ielasi
First Name & Middle Initial & Last Name & Degree
Alfonso Ielasi
Facility Name
Clinica Polispecialistica San Carlo
City
Paderno Dugnano
ZIP/Postal Code
20037
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido Belli
First Name & Middle Initial & Last Name & Degree
Guido Belli
Facility Name
Ospedale Sandro Pertini
City
Roma
ZIP/Postal Code
00157
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Sciahbasi
First Name & Middle Initial & Last Name & Degree
Alessandro Sciahbasi
Facility Name
Azienda Ospedaliero-Universitaria Sant'Andrea
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Rigattieri
First Name & Middle Initial & Last Name & Degree
Stefano Rigattieri
Facility Name
Policlinico Tor Vergata
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Sangiorgi
First Name & Middle Initial & Last Name & Degree
Giuseppe Sangiorgi
Facility Name
Ospedale S. Antonio Abate
City
Trapani
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dario Buccheri
First Name & Middle Initial & Last Name & Degree
Dario Buccheri
Facility Name
OLVG Onze Lieve Vrouwe Gasthuis location East
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vink M.A
Facility Name
Albert Schweitzer Hospital
City
Dordrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Oemrawsingh
Facility Name
Medical Center Leeuwarden
City
Leeuwarden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sjoerd Hofma
Facility Name
Maasstad Hospital
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Paradies
Facility Name
Hospital General Universitario de Ciudad Real (HGUCR)
City
Ciudad Real
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Sanchez-Perez
Facility Name
Hospital Universitario de Araba
City
Gasteiz / Vitoria
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Torres-Bosco
Facility Name
Hospital Universitario Lucus Augusti (HULA)
City
Lugo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymundo Ocaranza Sánchez
Facility Name
Hospital de La Princesa
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Alfonso
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Moreno Gómez
Facility Name
Hospital Universitario Marqués de Valdecilla (HUMV)
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José María de la Torre Hernández

12. IPD Sharing Statement

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

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