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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Restenoses, Coronary

Intervention / Treatment
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* Device: Drug eluting stent (DES)
* Device: Drug coated ballloon (DCB)


Participation Criteria
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Eligibility Criteria
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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. Previous treatment of the target lesion due to restenosis. 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. Patient's inability to fully comply with the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: homogenous<br>Stratification - homogenous pattern | Device: Drug eluting stent (DES)<br>* DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)<br>Device: Drug coated ballloon (DCB)<br>* DCB angioplasty with a paclitaxel-coated balloon (Agent, Boston Scientific)<br>|
| Other: heterogenous<br>Stratification - homogenous pattern | Device: Drug eluting stent (DES)<br>* DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)<br>Device: Drug coated ballloon (DCB)<br>* DCB angioplasty with a paclitaxel-coated balloon (Agent, Boston Scientific)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | all-cause death myocardial infarction target lesion revascularization (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 |