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

Sponsor

Fondazione Ricerca e Innovazione Cardiovascolare ETS (Other)

Overall Status

Recruiting

CT.gov ID

NCT04893291

Collaborator

(none)

1,325

Enrollment

Locations

Arms

84.5

Anticipated Duration (Months)

132.5

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Artery Stenosis	Device: Everolimus Eluting Stent Device: Sirolimus Coated Balloon	N/A

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

Study Type:

Interventional

Anticipated 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 :

Nov 16, 2021

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2028

Arms and Interventions

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

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

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Fondazione Poliambulanza	Brescia	Italy	25124
2	Ospedale Policlinico San Martino	Genova	Italy
3	Ospedale Civile Sant'Andrea	La Spezia	Italy
4	ASST Grande Ospedale Metropolitano Niguarda	Milano	Italy
5	Istituto clinico Sant'Ambrogio	Milano	Italy
6	Clinica Polispecialistica San Carlo	Paderno Dugnano	Italy	20037
7	Ospedale Sandro Pertini	Roma	Italy	00157
8	Azienda Ospedaliero-Universitaria Sant'Andrea	Roma	Italy
9	Policlinico Tor Vergata	Roma	Italy
10	Ospedale S. Antonio Abate	Trapani	Italy