About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Drug eluting stent (DES)
- Drug coated ballloon (DCB)
Treatment groups
Sponsors and collaborators
Deutsches Herzzentrum Muenchen
Lead sponsor
EvidentIQ Germany GmbH
Collaborator
Abbott
Collaborator
Technical University of Munich
Collaborator