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New treatment option for Calcified Atheroma
Official title ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial
ClinicalTrials.gov ID: NCT05208749
What this study is testing
- What it's testing
- 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 incidental microvascular obstruction and peri-procedural myocardial infarction (PPMI), which occurs in about 10-15% of cases and is associated with increased rates of major adverse cardiovascular events (MACE).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- The subject has suffered a stroke or transient ischemic neurological attack or cerebrovascular accident within the past six months, or has any known...
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.