About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Degree of stent expansion
The degree of stent expansion will be assessed by measuring: * Minimum stent area on intracoronary imaging (MSA) * Stent expansion (SE)
Sponsors and contacts
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