Actively Recruiting
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
Led by Deutsches Herzzentrum Muenchen · Updated on 2025-01-06
376
Participants Needed
5
Research Sites
204 weeks
Total Duration
On this page
Sponsors
D
Deutsches Herzzentrum Muenchen
Lead Sponsor
E
EvidentIQ Germany GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with ischemic symptoms and/or evidence of myocardial ischemia
- At least 50% restenosis after prior drug-eluting stent implantation in native coronary vessels
- Availability of optical coherence tomography (OCT) imaging of the target lesion
- Written informed consent for study participation
- Age 18 years or older
You will not qualify if you...
- Cardiogenic shock
- Acute ST-elevation myocardial infarction within 48 hours of symptom onset
- Target lesion located in left main trunk or bypass graft
- Planned additional coronary intervention within 30 days
- Unsuccessful treatment of other lesions during the same procedure
- Severe renal insufficiency (glomerular filtration rate 30 ml/min or less)
- Contraindications to components of study devices or dual antiplatelet therapy
- Pregnancy (present, suspected, or planned) or positive pregnancy test
- Previous enrollment in this trial or participation in another study at enrollment
- Malignancies or other conditions with life expectancy under 12 months or affecting compliance
- Inability to fully comply with the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany, D-60596
Actively Recruiting
2
Elisabeth-Krankenhaus Essen GmbH
Essen, Germany, 45138
Actively Recruiting
3
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, D-20246
Actively Recruiting
4
Deutsches Herzzentrum München
Munich, Germany, 80636
Actively Recruiting
5
Hospital Universitario de La Princesa Madrid
Madrid, Madrid, Spain, 28006
Actively Recruiting
Research Team
F
Felix Voll, MD
CONTACT
S
Salvatore Cassese, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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