RecruitingNot Applicable

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

Germany, Spain376 participantsStarted 2022-09-28

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Composite endpoint of major adverse cardiac event (MACE)

Timeframe: 24 months of clinical follow-up after randomization

Trial details

NCT IDNCT05544864

SponsorDeutsches Herzzentrum Muenchen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Felix Voll, MD

+49 89 1218 2749 voll@dhm.mhn.de

View on ClinicalTrials.gov More Coronary Artery Disease trials