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

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 design

Treatments tested in this trial

  • Not listed

Trial groups

1,260 Participants
are grouped into 1 trial group