Overview
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.
Eligibility
Inclusion Criteria:
- Patients with ischemic symptoms and/or evidence of myocardial ischemia
- Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
- Availability of an OCT-pullback of the target lesion
- Written informed consent by the patient for participation in the study.
- Age ≥ 18 years
Exclusion Criteria:
- Cardiogenic shock
- Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
- Target lesion located in left main trunk or bypass graft.
- Additional coronary intervention planned within 30 days of the procedure.
- Non-successful treatment of other lesion(s) during the same procedure
- Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
- Contraindications to any components of the investigational devices or dual antiplatelet therapy
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Previous enrollment in this trial or participation in any other study at the time of enrollment.
- Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.
- Patient's inability to fully comply with the study protocol