NCT07382154Not yet recruiting
Target Vessel Failure After Laser Assisted Percutaneous Angioplasty Versus Balloon-based Treatment for Drug Eluting In-stent Restenosis
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1260 (estimated)
- First submitted
- 26 Jan 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- NCT number
- NCT07382154
What you commit to
- Study type: Observational
- Planned participants: 1260
- From 1 Feb 2026 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Policlinico di Sant'Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.