To determine the change in plaque characteristics after treatment with DEB of additional LRPs, as measured by IVUS / NIRS, in ACS patients.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in LCBImm4 between baseline and 9 months in DEB-treated LRPs
Secondary outcome
• The change in lipid-core burden index in a 4 mm segment (LCBImm4) as measured
with IVUS + NIRS from baseline to 9 month follow-up in identified additional
LRPs that are not treated with DEB.
• Flow-limiting dissection necessitating bail-out stent implantation;
• Periprocedural myocardial infarction;
• LRP lesion failure, defined as cardiac death, myocardial infarction, or
ischemia-driven revascularization related to an identified non-culprit LRP
lesion up to one-year follow-up;
• Patient-oriented composite outcomes, defined as all-cause mortality,
myocardial infarction, or any repeat revascularization up to one-year follow-up;
• Additional IVUS + NIRS lesion characteristics (plaque volume, minimal lumen
area).
Background summary
Two thirds of the intracoronary thrombi that cause acute coronary syndrome
(ACS) result from the rupture of lipid-rich plaques (LRP). After treatment of
the culprit in ACS patients, additional LRPs are found in approximately 50% of
patients. Near-infrared spectroscopy (NIRS) in combination with intracoronary
ultrasound (IVUS) can identify these vulnerable plaques during coronary
angiography (CAG) and is able to assess plaque characteristics and the lipid
core burden index in a segment of 4 mm (LCBImm4). It is currently unknown
whether treatment of LRPs results in plaque stabilization, possibly reducing
the number of subsequent ACS. Previous imaging and animal studies have shown
that paclitaxel has a stabilizing effect on plaques with a possible reduction
in lipid content.
We hypothesize that LRPs can be treated with balloons coated with paclitaxel
(i.e., drug-eluting balloons; DEB) to provide a selective pharmacotherapeutic
treatment to arrest the local atherosclerotic process.
Study objective
To determine the change in plaque characteristics after treatment with DEB of
additional LRPs, as measured by IVUS / NIRS, in ACS patients.
Study design
Prospective single-arm clinical trial
Intervention
DEB-treatment of LRP, 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.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL75566.018.20 |