NCT05544864Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 376 (estimated)
- First submitted
- 9 Sept 2022
- Start date
- 28 Sept 2022
- Primary completion date
- Sept 2026
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Diseases
- Coronary artery disease
- NCT number
- NCT05544864
What you commit to
- Study type: Interventional
- Planned participants: 376
- From 28 Sept 2022 to the primary completion date, Sept 2026
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elisabeth-Krankenhaus Essen GmbH Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitätsklinikum Frankfurt Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Universitätsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Deutsches Herzzentrum München Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Hospital Universitario de la Princesa, Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.