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Clinical Trials in Italy / NCT07382154
Starting soon Observational

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

NCT07382154 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2026-02
Last updated
2026-02-02

Condition(s) studied

In-stent Restenosis

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Number of "Target Vessel Failure" (TVF) — 1 year after the procedure
    The TVF number will be calculated by considering the number of patients who experienced at least one of the events that make up the primary TVF outcome (cardiac death due to heart attack, non-fatal myocardial infarction, clinically guided revascularization, angiographic restenosis) in the group treated with balloon-based techniques and in the group treated with ELCA.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Policlinico di Sant'Orsola Bologna Italy

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Other trials for the same condition

Functional Milk Supplementation to Reduce In-Stent Restenosis in STEMI Patients (SMASOEA Trial) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07382154 on ClinicalTrials.gov ↗ ← All trials in Italy