CompletedNot Applicable

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

Italy110 participantsStarted 2023-05-23

Plain-language summary

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

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

late lumen loss at 9 months measured by quantitative coronary angiography

Timeframe: 18 months

incidence of adverse clinical events

Timeframe: 18 months

NCT IDNCT05471245

SponsorFondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-08

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;