Recruiting NCT05544864
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug eluting stent (DES), Drug coated ballloon (DCB).
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Restenoses, Coronary. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Drug eluting stent (DES)
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular) - Device Drug coated ballloon (DCB)
DCB angioplasty with any commercially available drug-coated balloon
Primary outcome measures
- Composite endpoint of major adverse cardiac event (MACE) [Time frame: 24 months of clinical follow-up after randomization]
Secondary outcome measures (4)
- Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR [Time frame: 24 months of clinical follow-up after randomization]
- Individual endpoints of the composite endpoints [Time frame: 24 months of clinical follow-up after randomization]
- Stent thrombosis according to the ARC criteria [Time frame: 24 months of clinical follow-up after randomization]
- Safety endpoint: a composite endpoint of all-cause death and myocardial infarction [Time frame: 24 months of clinical follow-up after randomization]
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.
- Patient's inability to fully comply with the study protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 4 centers
- Universitätsklinikum Frankfurt — Frankfurt am Main
- Elisabeth-Krankenhaus Essen GmbH — Essen
- Universitätsklinikum Hamburg-Eppendorf — Hamburg
- Deutsches Herzzentrum München — Munich
Spain · 1 center
- Hospital Universitario de La Princesa Madrid — Madrid
Publications
- Simonetti F, Voll F, Alfonso F, Grasser C, Janisch M, Joner M, Kessler T, Kuna C, Leistner DM, Lenz T, Presch A, Rheude T, Sager H, Schunkert H, Starnecker F, Wiebe J, Kastrati A, Cassese S, Xhepa E. 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: Rat PMID 40588613
Identifiers
NCT: NCT05544864 · GE IDE no. BA00219