AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyAllDeutsches Herzzentrum Muenchen
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with ischemic symptoms and/or evidence of myocardial ischemia 2. Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels. 3. Availability of an OCT-pullback of the target lesion 4. Written informed consent by the patient for participation in the study. 5. Age ≥ 18 years Exclusion Criteria: 1. Cardiogenic shock 2. Acute ST-elevation myocardial infarction within 48 hours from symptom onset. 3. Target lesion located in left main trunk or bypass graft. 4. Additional coronary intervention planned within 30 days of the procedure. 5. Non-successful treatment of other lesion(s) during the same procedure 6. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min) 7. Contraindications to any components of the investigational devices or dual antiplatelet therapy 8. Pregnancy (present, suspected or planned) or positive pregnancy test. 9. Previous enrollment in this trial or participation in any other study at the time of enrollment. 10. Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance. 11. Patient's inability to fully comply with the study protocol
💊

What it tests

  • Drug eluting stent (DES)
  • Drug coated ballloon (DCB)
📍

Where

5 sites
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Deutsches Herzzentrum München
Munich, Germany
Hospital Universitario de La Princesa Madrid
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy