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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,260 Participants
are grouped into 1 trial group
Group A: patients aged ≥ 18 years who have undergone coronary angioplasty for DES restenosis

Trial outcomes

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.

Time frame
1 year after the procedure

Secondary outcomes

1

Degree of stent expansion

The degree of stent expansion will be assessed by measuring: * Minimum stent area on intracoronary imaging (MSA) * Stent expansion (SE)

Time frame
During the procedure

Other outcomes

Sponsors and contacts

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