DEBuT-LRP study: Non-invasive and Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques

Phase 2

Withdrawn

• Conditions: myocardial infarction; 10011082

• Registration Number: NL-OMON49521
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 40

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);
6. Technical aspects hampering appropriate CT assessment (i.e. the presence of
extreme calcifications or extreme tortuosity);
7. Unstable patients (the presence of cardiogenic shock, need for intubation,
need for inotropes);
8. Patients with ST-segment elevations on the ECG requiring immediate primary
PCI;
9. Body weight > 250 kg;
10. Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <30
mL/min/1.73m2 or subject on dialysis);
11. Hypersensitivity or allergy to contrast with inability to properly
pre-hydrate;
12. Presence of a comorbid condition with a life expectancy of less than one
year;
13. Participation in another trial;
14. 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</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Changes in plaque volume and characteristics of LRPs treated with DEB<br /><br>measured by CTCA at 9-month follow-up, as compared to baseline;<br /><br>* Changes in perivascular fat as measured by CTCA at 9-month follow-up, as<br /><br>compared to baseline;<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);<br /><br>* Correlation of vulnerable plaque characteristics on CTCA with IVUS + NIRS at<br /><br>9-months follow-up.</p><br>