Comparing two treatments for coronary arteries that narrowed again after stenting
Compares a drug-eluting stent with a drug-coated balloon in adults with repeated artery narrowing.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Madrid, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose earlier drug-eluting heart stent has narrowed again and who have symptoms or signs of poor blood flow to the heart.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- At least 50% narrowing of a heart artery after an earlier drug-eluting stent was placed, with symptoms or signs of poor blood flow to the heart. An OCT scan of the narrowed spot must be available.
- Earlier treatment
- A drug-eluting stent must have been placed earlier in a native coronary artery.
Main reasons for not taking part
- Cardiogenic shock
- ST-elevation heart attack within the last 48 hours
- Narrowing in the left main trunk or in a bypass graft
- Severe kidney problems (glomerular filtration rate of 30 ml/min or less)
- Pregnancy (present, suspected or planned)
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitario de la Princesa, MadridMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Deutsches Herzzentrum Muenchen
- Trial code
- NCT05544864
- Record updated
- 6 January 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Contraindications to any components of the investigational devices or dual antiplatelet therapy; Previous enrollment in this trial or participation in any other study at the time of enrollment; Acute ST-elevation myocardial infarction within 48 hours from symptom onset; Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min); Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance; Cardiogenic shock; 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; Pregnancy (present, suspected or planned) or positive pregnancy test; Patient's inability to fully comply with the study protocol.