Clinical trial 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
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Restenoses, Coronary
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: EvidentIQ Germany GmbH
name: Abbott
name: Technical University of Munich
First posted: 2022-09-19
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint of major adverse cardiac event (MACE)
timeFrame: 24 months of clinical follow-up after randomization
Secondary outcomes:
measure: Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR
timeFrame: 24 months of clinical follow-up after randomization
measure: Individual endpoints of the composite endpoints
timeFrame: 24 months of clinical follow-up after randomization
measure: Stent thrombosis according to the ARC criteria
timeFrame: 24 months of clinical follow-up after randomization
measure: Safety endpoint: a composite endpoint of all-cause death and myocardial infarction
timeFrame: 24 months of clinical follow-up after randomization
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa Madrid
state: Community Of Madrid
Study officials:
References: