Coronary Artery Disease, Restenoses, Coronary
Conditions
Brief 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.
Interventions
DEVICEDrug eluting stent (DES)
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
DEVICEDrug coated ballloon (DCB)
DCB angioplasty with any commercially available drug-coated balloon
Sponsors
EvidentIQ Germany GmbH
Abbott
Technical University of Munich
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of major adverse cardiac event (MACE) | 24 months of clinical follow-up after randomization | Composite endpoint of major adverse cardiac event (MACE) * all-cause death * myocardial infarction * target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR | 24 months of clinical follow-up after randomization | — |
| Individual endpoints of the composite endpoints | 24 months of clinical follow-up after randomization | * all-cause death * myocardial infarction * target lesion revascularization (TLR) |
| Stent thrombosis according to the ARC criteria | 24 months of clinical follow-up after randomization | — |
| Safety endpoint: a composite endpoint of all-cause death and myocardial infarction | 24 months of clinical follow-up after randomization | — |
Countries
Germany, Spain
Contacts
Primary ContactFelix Voll, MD
Backup ContactSalvatore Cassese, MD, PHD
Outcome results
None listed