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

Launched by FONDAZIONE EVIDENCE PER ATTIVITÀ E RICERCHE CARDIOVASCOLARI ONLUS · Jul 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special type of balloon called the Sirolimus-eluting balloon, which is used to treat long blockages in the coronary arteries (the blood vessels that supply the heart). The goal is to see how well this balloon works for patients with coronary artery disease who need a procedure called percutaneous coronary intervention (PCI) to open up blocked arteries. The study is currently looking for participants who are 18 years or older, have stable or unstable coronary artery disease, and have specific types of blockages that meet certain size criteria.

If you or a loved one qualifies for this trial, you can expect to undergo a procedure where the Sirolimus-eluting balloon is used to treat the blockage. Participants will need to commit to follow-up appointments for up to 9 months after the procedure to monitor their progress. It's important to note that there are some conditions that would exclude someone from participating, such as being pregnant, having certain serious medical conditions, or having specific types of blockages that the trial does not cover. Overall, this study aims to find out if this new treatment can help improve outcomes for people with coronary artery disease.

Gender

ALL

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.