NL-OMON49521
Withdrawn
Phase 2
DEBuT-LRP study: Non-invasive and Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques - DEBuT-LRP
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- myocardial infarction
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 40
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient has an acute coronary syndrome without ST\-segment elevation on the
- •ECG (NSTE\-ACS), including non\-ST\-elevation myocardial infarction and unstable
- •angina pectoris.
- •2\. An invasive revascularization strategy for NSTE\-ACS with PCI is chosen.
- •3\. The coronary arteries are open and patent on CTCA, thus feasible to scan all
- •major coronary arteries with IVUS/NIRS.
Exclusion Criteria
- •Angiographic exclusion criteria:
- •1\. Patient has additional lesions that cannot be treated during the index PCI
- •and need staged PCI;
- •2\. A chronic total occlusion is present;
- •3\. Previous coronary artery bypass\-grafting;
- •4\. Patient has a major procedural complication of the index PCI (coronary
- •perforation, coronary dissection);
- •Clinical exclusion criteria:
- •5\. Irregular heart rhythm, affecting the CT quality (i.e. atrial fibrillation
- •or frequent premature ventricular contractions);
Outcomes
Primary Outcomes
Not specified
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