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

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease, Restenoses, Coronary

In brief

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.

Key facts

Study ID

NCT05544864

Run by

Deutsches Herzzentrum Muenchen

People needed

376

Starts

2022-09-28

Expected to finish

2026-09-01

Last updated by the study team

2025-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Universitätsklinikum Frankfurt — Frankfurt am Main, Hesse, Germany (enrolling)
• Elisabeth-Krankenhaus Essen GmbH — Essen, Germany (enrolling)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Deutsches Herzzentrum München — Munich, Germany (enrolling)
• Hospital Universitario de La Princesa Madrid — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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