Evaluating a Sirolimus-Eluting Balloon for Treating Coronary Artery Disease

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

This study is testing a special balloon treatment for people with new coronary artery disease to see if it helps improve blood flow and reduces heart problems after 9 months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS (other)
• Locations: 6 sites (Milan, Italy/MI and 5 other locations)
• Trial ID: NCT05471245 on ClinicalTrials.gov

What this trial studies

This study assesses the angiographic performance of the Magic Touch Sirolimus-Coated Balloon in patients with de novo coronary artery disease undergoing percutaneous coronary intervention. The primary focus is on measuring late lumen loss and mean net lumen diameter gain at the treated segment after 9 months. Secondary endpoints include procedural success, rates of myocardial infarction, and binary restenosis rates, with follow-ups at various intervals to monitor outcomes. The study aims to provide insights into the effectiveness of this treatment option for long lesions in coronary arteries.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with stable or unstable coronary artery disease eligible for PCI and specific lesion characteristics.

Not a fit: Patients under 18 or those participating in other clinical evaluations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with coronary artery disease by reducing restenosis rates and enhancing angiographic performance.

How similar studies have performed: Other studies have shown promise with sirolimus-eluting technologies, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria

1. Age \>18 years
2. 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);
3. Reference vessel diameter (RVD) at the SCB target site ≥2.0 mm and ≤4.0 mm (by visual estimation and/or quantitative coronary angiography);
4. Lesion length at the SCB target site ≥25 mm;
5. 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;
6. SCB-target lesion located in the same or other vessels treated by drug-eluting stent (DES) implantation;
7. Patient able to understand and provide informed consent and comply with all study procedures including 9 months angiographic follow-up.

Exclusion criteria:

1. Patients participating in another clinical evaluation;
2. Age \<18 years;
3. Cardiogenic shock;
4. 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;
5. Thrombus containing lesion;
6. 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;
7. Comorbidities with life expectancy \<6 months;
8. 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;
9. Target lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft;
10. 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);
11. Severe chronic kidney disease (glomerular filtration rate\<30 ml/min/1.73 m2);
12. Platelet count \<50,000cells/mm;
13. Stroke within the previous 6 months;
14. 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.

Where this trial is running

Milan, Italy/MI and 5 other locations

• IRCCS Ospedale San Raffaele — Milan, Italy/MI, Italy (ACTIVE_NOT_RECRUITING)
• Centro Cardiologico Monzino — Milan, Italy/MI, Italy (RECRUITING)
• IRCCS Ospedale Galeazzi Sant'Ambrogio — Milan, Italy/MI, Italy (RECRUITING)
• Policlinico Tor Vergata — Rome, Italy/RM, Italy (RECRUITING)
• AULSS 2 Marca Trevigiana Ospedale di Conegliano — Conegliano, Italy/TV, Italy (RECRUITING)
• Ospedale Santa Maria della Misericordia — Udine, Italy/UD, Italy (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: Alfonso Ielasi, MD

Conditions: Coronary Restenosis, QCA, late loss, sirolimus eluting balloon