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

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Conditions studied: In-stent Restenosis

In brief

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.

Key facts

Study ID

NCT07382154

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

1260

Starts

2026-02-01

Expected to finish

2028-07-01

Last updated by the study team

2026-02-02

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥ 18 years who have undergone coronary angioplasty for restenosis of a drug-eluting stent in at least one coronary vessel
• Acquisition of written informed consent from patients included in the study
• 1-year follow-up in patients in the retrospective cohort

You may not qualify if…

• concurrent presence of a new angiographically significant lesion on the coronary artery treated for ISR
• hybrid treatment of two or more drug-eluting stent restenoses in the same angioplasty procedure. That is, treatment of one or more restenoses with balloon-based therapy alone and treatment of one or more restenoses using the ELCA technique in the same angioplasty procedure.
• inability to take dual antiplatelet therapy for the period required by the coronary angioplasty procedure 4) life expectancy < 1 year

Where it is running

• IRCCS Policlinico di Sant'Orsola — Bologna, Italy

Full record on ClinicalTrials.gov

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