Status:
UNKNOWN
Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 9 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04765956
Start Date
January 19 2021
End Date
September 9 2023
Last Update
February 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105AZ