Status:
RECRUITING
ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Ziekenhuis Oost-Limburg
University Hospital, Ghent
Conditions:
Calcified Atheroma
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries. However, the efficacy of PCI may be compromised by inc...
Detailed Description
In this multicentre, prospective, randomized-controlled open label pilot study the investigators will measure rates of peri-procedural myocardial infarction and changes in microvascular function after...
Eligibility Criteria
Inclusion
- Patient older than 18 years.
- The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.
- The subject is eligible for PCI.
- The subject gives consent prior to study inclusion.
- The subject has a calcified lesion that does not dilated fully after balloon angioplasty at 16atm with a ≥2.5mm non-compliant balloon.
- The calcified lesion has a 50-90% diameter stenosis by angiographic assessment.
Exclusion
- Previous and/or planned brachytherapy of target vessel.
- Pregnant and/or breast-feeding females or females who intend to become pregnant.
- Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
- Patients who previously participated in this study.
- Subject has experienced an acute myocardial infarction 72 hours prior to the index procedure, as defined either by the presence of a new Q-wave in 2 or more contiguous leads, or by a CK greater than two times site upper reference limit (URL) with presence of CK-MB greater than the site URL.
- The subject has suffered a stroke or transient ischemic neurological attack or cerebrovascular accident within the past six months, or has any known intracranial mass, arteriovenous malformation, aneurysm or other intracranial pathology.
- The subject has experienced a significant gastrointestinal or genitourinary bleed within the past six months, or has had any active bleeding within two months.
- Planned revascularization of target vessel within 1 year after index procedure.
- Lesions not ideal for Shockwave treatment:
- Longer than 40mm.
- The target vessel contains intraluminal thrombus.
- The subject has had a prior stent in the target lesion, including a 5mm zone proximal and distal to the lesion.
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05208749
Start Date
February 4 2022
End Date
January 1 2025
Last Update
July 3 2024
Active Locations (1)
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1
University Hopsitals Leuven
Leuven, Brabant, Belgium, 3000