Comparing drug-eluting stents and drug-coated balloons for coronary artery disease treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of drug-eluting stents versus drug-coated balloons in patients experiencing restenosis after previous stent implantation. It focuses on the interaction between the morphology of neointima, as assessed by optical coherence tomography (OCT), and the type of intervention used. Patients with significant restenosis and ischemic symptoms will be randomized to receive either treatment, with the aim of determining which approach yields better outcomes based on neointima characteristics.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Felix Voll, MD
• Email: voll@dhm.mhn.de
• Phone: +49 89 1218 2749

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.