Back to resultsIntravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques (DEBuT-LRP)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Drug-eluting balloon treatment
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Lipid-rich plaque, Non-ST-elevation myocardial infarction, Near-infrared spectroscopy, Drug-eluting balloon
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:
- Previous coronary artery bypass-grafting;
- Presence of a chronic total occlusion;
- Too many (complex) coronary lesions requiring staged PCI procedure(s);
Procedural complication of the index PCI;
- Clinical exclusion criteria:
- Unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes);
- Patients with ST-segment elevations on the ECG requiring immediate primary PCI;
- Body weight > 250 kg;
- Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73m2 or subject on dialysis);
- Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;
- Presence of a comorbid condition with a life expectancy of less than one year;
- Participation in another trial;
- Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.
Sites / Locations
- Amsterdam UMC, location AMCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug-eluting balloon treatment
Arm Description
Drug-eluting balloon (DEB) treatment of lipid-rich plaque
Outcomes
Primary Outcome Measures
LCBImm4 difference of DEB-treated LRPs
The difference in LCBImm4 between baseline and 9 months follow-up of lipid-rich plaques treated with drug-eluting balloon, as measured with near-infrared spectroscopy (NIRS).
Secondary Outcome Measures
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.
Rate of flow-limiting dissections necessitating bail-out stent implantation;
Rate of periprocedural myocardial infarction;
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);
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
Additional IVUS + NIRS lesion characteristics: minimal lumen area
Full Information
NCT ID
NCT04765956
First Posted
February 18, 2021
Last Updated
January 31, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT04765956
Brief Title
Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
Acronym
DEBuT-LRP
Official Title
Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
September 9, 2023 (Anticipated)
Study Completion Date
September 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Lipid-rich plaque, Non-ST-elevation myocardial infarction, Near-infrared spectroscopy, Drug-eluting balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective single-arm clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug-eluting balloon treatment
Arm Type
Experimental
Arm Description
Drug-eluting balloon (DEB) treatment of lipid-rich plaque
Intervention Type
Device
Intervention Name(s)
Drug-eluting balloon treatment
Intervention Description
Drug-eluting balloon (DEB) treatment of lipid-rich plaque
Primary Outcome Measure Information:
Title
LCBImm4 difference of DEB-treated LRPs
Description
The difference in LCBImm4 between baseline and 9 months follow-up of lipid-rich plaques treated with drug-eluting balloon, as measured with near-infrared spectroscopy (NIRS).
Time Frame
9 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
9 months
Title
Rate of flow-limiting dissections necessitating bail-out stent implantation;
Time Frame
9 months
Title
Rate of periprocedural myocardial infarction;
Time Frame
9 months
Title
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);
Time Frame
1 year
Title
Patient-oriented composite outcomes, defined as all-cause mortality, myocardial infarction, or any repeat revascularization up to one-year follow-up;
Time Frame
1 year
Title
Additional IVUS + NIRS lesion characteristics: plaque volume
Time Frame
9 months
Title
Additional IVUS + NIRS lesion characteristics: minimal lumen area
Time Frame
9 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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:
Previous coronary artery bypass-grafting;
Presence of a chronic total occlusion;
Too many (complex) coronary lesions requiring staged PCI procedure(s);
Procedural complication of the index PCI;
- Clinical exclusion criteria:
Unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes);
Patients with ST-segment elevations on the ECG requiring immediate primary PCI;
Body weight > 250 kg;
Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73m2 or subject on dialysis);
Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;
Presence of a comorbid condition with a life expectancy of less than one year;
Participation in another trial;
Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Henriques
Phone
+31205669111
Email
j.p.henriques@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Anna van Veelen
Email
a.vanveelen@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Henriques
Email
j.p.henriques@amsterdamumc.nl
12. IPD Sharing Statement
Learn more about this trial
Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
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