Coronary Artery Disease Clinical Trial
— ISAR-DESIRE5Official 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
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 | Recruiting |
Enrollment | 376 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | Theodor-Stern-Kai 7 |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Deutsches Herzzentrum München | Munich |
Lead Sponsor | Collaborator |
---|---|
Deutsches Herzzentrum Muenchen | Abbott, EvidentIQ Germany GmbH, Institute of AI and Informatics in Medicine Technical University of Munich |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite endpoint of major adverse cardiac event (MACE) | Composite endpoint of major adverse cardiac event (MACE)
all-cause death myocardial infarction target lesion revascularization (TLR) |
24 months of clinical follow-up after randomization | |
Secondary | Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR | 24 months of clinical follow-up after randomization | ||
Secondary | Individual endpoints of the composite endpoints | all-cause death
myocardial infarction target lesion revascularization (TLR) |
24 months of clinical follow-up after randomization | |
Secondary | Stent thrombosis according to the ARC criteria | 24 months of clinical follow-up after randomization | ||
Secondary | Safety endpoint: a composite endpoint of all-cause death and myocardial infarction | 24 months of clinical follow-up after randomization |
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