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

ConditionsCoronary Artery Disease Restenoses, Coronary

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Drug eluting stent (DES)
Device
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
Drug coated ballloon (DCB)
Device
DCB angioplasty with any commercially available drug-coated balloon

Treatment groups

376 Participants

are divided into 2 treatment groups

Group A: homogenousOther 2 interventions

Group B: heterogenousOther 2 interventions

Trial outcomes

Primary outcomes

Composite endpoint of major adverse cardiac event (MACE)

Composite endpoint of major adverse cardiac event (MACE) * all-cause death * myocardial infarction * target lesion revascularization (TLR)

Time frame