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

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

This study is testing whether drug-eluting stents or drug-coated balloons work better for patients with coronary artery disease who have had a previous stent and are experiencing symptoms again.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 376 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Deutsches Herzzentrum Muenchen (Academic / other)
• Locations: 5 sites (Frankfurt am Main, Hesse and 4 other locations)
• Trial ID: NCT05544864 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with ischemic symptoms and at least 50% restenosis after prior drug-eluting stent placement.

Not a fit: Patients with acute myocardial infarction, severe renal insufficiency, or those requiring additional coronary interventions within 30 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with coronary artery disease and stent restenosis.

How similar studies have performed: Previous studies have shown varying success with drug-eluting stents and drug-coated balloons, but this specific approach based on neointima morphology is novel.

Eligibility criteria

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 this trial is running

Frankfurt am Main, Hesse and 4 other locations

• 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

Conditions Coronary Artery Disease; Restenoses, Coronary