DEBuT-LRP study: Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
- Conditions
- myocardial infarction10011082
- Registration Number
- NL-OMON54017
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
1. Patient has an acute coronary syndrome without ST-segment elevation on the
ECG (NSTE-ACS), includingnon-ST-elevation myocardial infarction and unstable
angina pectoris.
2. An invasive revascularization strategy for NSTE-ACS with PCI is chosen.
Angiographic exclusion criteria:
1. Previous coronary artery bypass-grafting;
2. A chronic total occlusion is present;
3. Too many (complex) coronary lesions requiring staged PCI procedure(s);
4. Procedural complication of the index PCI;
Clinical exclusion criteria:
5. Unstable patients (the presence of cardiogenic shock, need for intubation,
need for inotropes);
6. Patients with ST-segment elevations on the ECG requiring immediate primary
PCI;
7. Body weight > 250 kg;
8. Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <30
mL/min/1.73m2 or subject on dialysis);
9. Hypersensitivity or allergy to contrast with inability to properly
pre-hydrate;
10. Presence of a comorbid condition with a life expectancy of less than one
year;
11. Participation in another trial;
12. Subject is belonging to a vulnerable population (per investigator*s
judgment, e.g., subordinate hospital staff) or is unable to read or write.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in LCBImm4 between baseline and 9 months in DEB-treated LRPs</p><br>
- Secondary Outcome Measures
Name Time Method <p>• The change in lipid-core burden index in a 4 mm segment (LCBImm4) as measured<br /><br>with IVUS + NIRS from baseline to 9 month follow-up in identified additional<br /><br>LRPs that are not treated with DEB.<br /><br>• Flow-limiting dissection necessitating bail-out stent implantation;<br /><br>• Periprocedural myocardial infarction;<br /><br>• LRP lesion failure, defined as cardiac death, myocardial infarction, or<br /><br>ischemia-driven revascularization related to an identified non-culprit LRP<br /><br>lesion up to one-year follow-up;<br /><br>• Patient-oriented composite outcomes, defined as all-cause mortality,<br /><br>myocardial infarction, or any repeat revascularization up to one-year follow-up;<br /><br>• Additional IVUS + NIRS lesion characteristics (plaque volume, minimal lumen<br /><br>area).</p><br>