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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05544864
Other study ID # GE IDE no. BA00219
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 28, 2022
Est. completion date September 2026

Study information

Verified date March 2024
Source Deutsches Herzzentrum Muenchen
Contact Felix Voll, MD
Phone +49 89 1218
Email voll@dhm.mhn.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Drug eluting stent (DES)
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
Drug coated ballloon (DCB)
DCB angioplasty with any commercially available drug-coated balloon

Locations

Country Name City State
Germany Universitätsklinikum Frankfurt Frankfurt am Main Theodor-Stern-Kai 7
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Deutsches Herzzentrum München Munich

Sponsors (4)

Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen Abbott, EvidentIQ Germany GmbH, Institute of AI and Informatics in Medicine Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

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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