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

NCT07382154 | Not Yet Recruiting

• 1 other identifier: SONIC
• Study Type: observational
• Target: 1,260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

In-stent Restenosis

Keywords

in-stent restenosis; drug-eluting stents; Excimer Laser Coronary Atherectomy

Outcome Measures

Primary Outcomes (1)

• Number of "Target Vessel Failure" (TVF)

  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.

  1 year after the procedure

Secondary Outcomes (1)

• Degree of stent expansion

  During the procedure

Study Arms (1)

patients aged ≥ 18 years who have undergone coronary angioplasty for DES restenosis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study plans to enroll patients aged ≥ 18 years who have undergone coronary angioplasty for DES restenosis. It will be a retrospective and prospective multicenter national cohort study.

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
• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location

Central Study Contacts

Gabriele Ghetti, MD

CONTACT

+39 0512144475; gabriele.ghetti@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

IT (1)