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New treatment option for Coronary Artery Disease
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
ClinicalTrials.gov ID: NCT05544864
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Frankfurt am Main, Hesse, Germany
- Essen, Germany
- Hamburg, Germany
- Munich, Germany
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frankfurt am Main, Hesse, Germany; Essen, Germany; Hamburg, Germany; Munich, Germany; Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.