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

Deutsches Herzzentrum Muenchen5 sites in 2 countries376 target enrollmentSeptember 28, 2022

ConditionsCoronary Artery Disease Restenoses, Coronary

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Deutsches Herzzentrum Muenchen
Enrollment: 376
Locations: 5
Primary Endpoint: Composite endpoint of major adverse cardiac event (MACE)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 28, 2022

End Date

September 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Deutsches Herzzentrum Muenchen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•Cardiogenic shock
•Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
•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
•Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
•Contraindications to any components of the investigational devices or dual antiplatelet therapy
•Pregnancy (present, suspected or planned) or positive pregnancy test.
•Previous enrollment in this trial or participation in any other study at the time of enrollment.
•Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.

Outcomes

Primary Outcomes

Composite endpoint of major adverse cardiac event (MACE)

Time Frame: 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 Outcomes

Individual endpoints of the composite endpoints(24 months of clinical follow-up after randomization)
Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR(24 months of clinical follow-up after randomization)
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)