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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Restenoses, Coronary
• Interventions: Device: Drug eluting stent (DES); Device: Drug coated ballloon (DCB)

• Registration Number: NCT05544864
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-19
• Study Start: 2022-09-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 376

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
homogenous	Drug eluting stent (DES)	Stratification - homogenous pattern
homogenous	Drug coated ballloon (DCB)	Stratification - homogenous pattern
heterogenous	Drug coated ballloon (DCB)	Stratification - homogenous pattern
heterogenous	Drug eluting stent (DES)	Stratification - homogenous pattern

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Individual endpoints of the composite endpoints	24 months of clinical follow-up after randomization	* all-cause death; * myocardial infarction; * target lesion revascularization (TLR)
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

Trial Locations

Locations (5)

Hospital Universitario de La Princesa Madrid; 🇪🇸 Madrid, Community Of Madrid, Spain

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt am Main, Hessen, Germany

Elisabeth-Krankenhaus Essen GmbH; 🇩🇪 Essen, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany