Clinical trial NCT04765956: Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
Official title: Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Lipid-rich plaque
Non-ST-elevation myocardial infarction
Near-infrared spectroscopy
Drug-eluting balloon
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-arm clinical trial
Primary purpose: TREATMENT

Brief summary: Rationale: Two-thirds of intracoronary thrombi causing acute coronary syndrome (ACS) result from rupture of lipid-rich plaques (LRP). After treatment of the culprit lesion in ACS patients, additional LRPs are found in approximately 50% of patients. Near infrared spectroscopy (NIRS) combined 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 4mm segment (LCBImm4). It is currently unknown whether treatment of LRPs leads to plaque stabilization, potentially reducing the number of subsequent ACS. We hypothesize that LRPs can be treated with balloons coated with an antiproliferative drug (i.e. drug-eluting balloons; DEB) to deliver selective pharmacotherapeutic treatment to halt the local atherosclerotic process and subsequently reduce the risk for atherosclerotic events.

Objectives: To determine the change in plaque characteristics of non-culprit LRPs, as measured with IVUS/NIRS, after treatment with DEB in patients with ACS.

Study design: Prospective single-arm clinical trial

Study population: Patients with non-ST-elevation acute coronary syndromes

Intervention: If a LRP is detected with IVUS/NIRS, it will be treated with DEB. In case multiple LRPs are detected, only one will be treated.

Main study endpoints: The difference in LCBImm4 between baseline and 9 months of plaques treated with DEB.


Eligibility criteria: Inclusion Criteria:

* 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, defined according to the Fourth Universal Definition of Myocardial Infarction.
* An invasive revascularization strategy for NSTE-ACS with PCI is chosen.

Exclusion Criteria:

- Angiographic exclusion criteria:

1. Previous coronary artery bypass-grafting;
2. Presence of a chronic total occlusion;
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.

Primary outcomes:
measure: LCBImm4 difference of DEB-treated LRPs
timeFrame: 9 months
Secondary outcomes:
measure: 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.
timeFrame: 9 months
measure: Rate of flow-limiting dissections necessitating bail-out stent implantation;
timeFrame: 9 months
measure: Rate of periprocedural myocardial infarction;
timeFrame: 9 months
measure: Rate of 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);
timeFrame: 1 year
measure: Patient-oriented composite outcomes, defined as all-cause mortality, myocardial infarction, or any repeat revascularization up to one-year follow-up;
timeFrame: 1 year
measure: Additional IVUS + NIRS lesion characteristics: plaque volume
timeFrame: 9 months
measure: Additional IVUS + NIRS lesion characteristics: minimal lumen area
timeFrame: 9 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
References: