To test the hypothesis that paclitaxel-coated balloon treatment of vulnerable lipid-rich plaques leads to a greater reduction of the lipid-core burden index than guideline-directed medical therapy alone.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>The difference in maxLCBImm4 reduction from baseline to 9 months follow-up compared between the two randomization groups.</p>
Secondary outcome
<p>Secondary imaging endpoints: </p><ul><li>The change in lipid-core burden index in maxLCBI4mm as measured with IVUS + NIRS from baseline to 9 month follow-up in identified additional LRPs that are not treated with DCB. </li><li>The change in IVUS- and angiography-derived measurements (plaque burden, minimal lumen area, mean plaque area, diameter stenosis and minimal lumen diameter). </li></ul><p>Secondary clinical endpoints: </p><ul><li>Flow-limiting dissection necessitating bail-out stent implantation; </li><li>Periprocedural myocardial infarction; </li><li>LRP lesion failure, defined as cardiovascular death, myocardial infarction, or ischemia-driven revascularization related to an identified non-culprit LRP lesion up to one-year follow-up; </li><li>Patient-oriented composite outcomes, defined as all-cause mortality, myocardial infarction, or any repeat revascularization up to one-year follow-up;</li></ul>
Background summary
Acute coronary syndromes (ACS) are often caused by rupture of certain high-risk vulnerable plaques. These plaques demonstrate specific features, such as a large lipid-rich necrotic core, a thin fibrous cap and inflammation. Half of patients presenting with non-ST-segment elevation ACS (NSTE-ACS) have an additional vulnerable plaque, which increases their risk for non-culprit events during follow-up. Coronary intravascular ultrasound (IVUS) with the addition of near-infrared spectroscopy (NIRS) enables the identification of coronary lesions with high lipid content, quantified using the lipid-core burden index (LCBI) and is therefore able to distinguish plaques at risk to cause future non-culprit events. The question remains whether local and systemic treatment of such high-risk plaques decreases the risk for adverse clinical outcome. In our previous pilot study, DEBuT-LRP, we demonstrated that it was safe and feasible to treat vulnerable lipid-rich plaques with a paclitaxel-coated balloon (PCB) and that it was able to reduce the maximum LCBI on a 4 mm segment (maxLCBImm4) after 9 months. In this randomized controlled trial, we intend to investigate the impact of PCB treatment on the LCBI of lipid-rich plaques when compared to guideline-directed medical therapy alone.
Study objective
To test the hypothesis that paclitaxel-coated balloon treatment of vulnerable lipid-rich plaques leads to a greater reduction of the lipid-core burden index than guideline-directed medical therapy alone.
Study design
A prospective two-arm randomized controlled trial.
Intervention
PCB-treatment of lipid-rich plaque, as detected with IVUS/NIRS.
Study burden and risks
Patients participating in this study are exposed to extra measurements during their primary intervention for ACS, a possible DEB treatment, and an extra coronary angiography after 9 months.
T.N. Dijkstra
Meibergdreef 9
Amsterdam 1105 AZ
Netherlands
0205669111
t.n.dijkstra@amsterdamumc.nl
T.N. Dijkstra
Meibergdreef 9
Amsterdam 1105 AZ
Netherlands
0205669111
t.n.dijkstra@amsterdamumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Patients aged 18 years or older
- Presenting with acute coronary syndrome, consisting of unstable angina pectoris or acute myocardial infarction with or without ST-segment elevation
- Successful PCI of a native coronary artery or major side branch
- At least 2 native coronary arteries are accessible for invasive coronary imaging; i.e. not totally occluded and >2 mm and <6 mm reference vessel diameter.
Exclusion criteria
- Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes);
- Known hypersensitivity to paclitaxel;
- Procedural complications of the index PCI;
- Known renal insufficiency, i.e. eGFR <30 mL/min/1.73 m2;
- Hypersensitivity or allergy to contrast with inability to administer steroid and antihistamine premedication;
- Presence of a comorbid condition with a life expectancy of less than one year;
- Body weight >250 kg;
- Subject belonging to a vulnerable population (per investigator’s judgment, e.g., subordinate hospital staff) or is unable to read or write.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Research portal | NL-009200 |