Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDeutsches Herzzentrum Muenchen

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

376 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Deutsches Herzzentrum Muenchen

Lead sponsor

EvidentIQ Germany GmbH

Collaborator

Abbott

Collaborator

Technical University of Munich

Collaborator