GINGER: AnGiographic Performance With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease

Sponsor

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05471245

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Evaluate angiographic performance in long lesions of Sirolimus Eluting Balloon Magic Touch by Concept Medical

Condition or Disease	Intervention/Treatment	Phase
Coronary Restenosis	Device: Magic Touch SCB by Concept Medical Inc.	N/A

Detailed Description

To assess the angiographic performance of the Magic Touch Sirolimus-Coated Balloon (SCB) at 9 months follow-up after PCI for de novo CAD.

Primary end-points:

Late lumen loss (LLL) at the SCB-treated segment within 9 months after the index procedure;
Mean net lumen diameter gain at the SCB-treated segment at 9 months angiographic follow-up.

Secondary end-points:

Procedural success defined as both SCB delivery and inflation at the "target" lesion site with <30% diameter stenosis (DS) in the SCB-treated segment and distal Thrombolysis In Myocardial Infarction (TIMI) 3 flow;
Peri-procedural myocardial infarction (PMI) defined according to the EXCEL trial (creatinine kinase myocardial band) or Society for Cardiovascular Angiography and Interventions definitions (troponin);
Binary restenosis rate at the SCB-treated segment at 9 months angiographic follow-up;
A Device Oriented Composite End-point (DOCE) and its singular components (cardiac death, any target-vessel myocardial infarction excluding PMI, ischemia-driven target lesion revascularization) in-hospital, within 7 days after PCI; phone follow-up at 30-day (+/- 7 days) and 12 months (+/- 1 month) and a follow-up visit at 9 months (+/- 1 month). Any definite/probable SCB-treated segment thrombosis (in-hospital, within 7 days after PCI and at 30-day, 9-month, 1-year follow-up).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

prospective enrolment of long lesionsprospective enrolment of long lesions

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

AnGiographic Performance Following PCI With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease: GINGER Study

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: angiographic evaluation QCA at 9 months	Device: Magic Touch SCB by Concept Medical Inc. PCI with drug-coated balloon

Arm

Intervention/Treatment

Experimental: angiographic evaluation

QCA at 9 months

Device: Magic Touch SCB by Concept Medical Inc.

PCI with drug-coated balloon

Outcome Measures

Primary Outcome Measures

late lumen loss at 9 months measured by quantitative coronary angiography [18 months]
QCA by core lab
incidence of adverse clinical events [18 months]
myocardial infarction, death, need for revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Age >18 years
Patients presenting with stable or unstable coronary artery disease (CAD) eligible for percutaneous coronary intervention (PCI) with de novo CAD in one or two separates major epicardial territories and at least one lesion suitable for sirolimus coated balloon (SCB);
Reference vessel diameter (RVD) at the SCB target site ≥2.0 mm and ≤4.0 mm (by visual estimation and/or quantitative coronary angiography);
Lesion length at the SCB target site ≥25 mm;
Successful lesion preparation (full and homogenous pre-dilatation balloon expansion without type C-F dissection and/or TIMI flow=3 at the SCB target site;
SCB-target lesion located in the same or other vessels treated by drug-eluting stent (DES) implantation;
Patient able to understand and provide informed consent and comply with all study procedures including 9 months angiographic follow-up.

Exclusion criteria:

Patients participating in another clinical evaluation;
Age <18 years;
Cardiogenic shock;
Pregnancy or breastfeeding women; 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;
Thrombus containing lesion;
Unprotected left main as a target lesion unless this lesion is treated with a DES and SCB inflated distally or on a branch or on a different vessel;
Comorbidities with life expectancy <6 months;
Aorto-ostial target lesion (within 3 mm of the aorta junction); unless this lesion is treated with a DES and SCB inflated distally or on a branch or on a different vessel;
Target lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft;
Every known allergy, intolerance or hypersensitivity to any medication used during the procedure and to drugs recommended after the procedure (e.g. aspirin, clopidogrel, ticagrelor, prasugrel);
Severe chronic kidney disease (glomerular filtration rate<30 ml/min/1.73 m2);
Platelet count <50,000cells/mm;
Stroke within the previous 6 months;
RVD at the SCB target site <2.0 mm or >4.0 mm (by visual estimation and/or QCA); target lesion with RVD larger than 4 mm can be treated with a DES and SCB inflated in other segments of the same or other vessels.