Clinical Trial

Target Vessel Failure After Laser Assisted Percutaneous Angioplasty Versus Balloon-based Treatment for Drug Eluting In-stent Restenosis

Study acronym: SONIC
Not Yet Recruiting
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Summary
Stent restenosis (ISR) is an increasingly common problem; in fact, approximately 10% of coronary angioplasty procedures involve the treatment of a previously implanted stent. In cases of ISR of drug-eluting stents, the rate of further restenosis remains high (approximately 13% at one year). The treatment of stent restenosis consists of the use of balloon-based methods. Some small, single-center observational studies suggest the effectiveness of Excimer Laser Coronary Atherectomy (ELCA) in this context, allowing for a wider coronary lumen, a better minimum stent area (MSA), and a numerically lower incidence of new stent restenosis. Demonstrating that Excimer Laser Coronary Atherectomy (ELCA)-assisted angioplasty treatment for DES ISR is associated with a lower incidence of Target Vessel Failure at 1 year compared to balloon-based angioplasty techniques may allow for better treatment of this type of patient.
Trial Details
NCT Number NCT07382154
Lead Sponsor IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions In-stent Restenosis
Enrollment 1,260 participants
Start Date 2026-02
Primary Completion 2027-10 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-02