ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions, the SONAR Trial. ;A randomized controlled trial comparing rates of peri-procedural myocardial infarction after intravascular ultrasound and rotational atherectomy in patients with calcified coronary artery lesions.
- Conditions
- severely calcified coronary arteries10011082
- Registration Number
- NL-OMON53616
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 65
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 moderate to severe calcified lesion with the expected need of
plaque modification, on the condition that with or without low profile balloon
(<= 1.5 mm) preparation, a >= 2.5 non-compliant balloon can cross the lesion.
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: difference in the rate of peri-procedural myocardial<br /><br>infarction (Type 4a of the universal Definition of Myocardial Infarction) in<br /><br>patients allocated to Shockwave IVL group versus RA group.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes: in centres where the index of microcirculatory resistance<br /><br>(IMR) can be measured before and after PCI, a rate of peri-procedural<br /><br>microvascular dysfunction will be measured. Other secondary outcomes:<br /><br>peri-procedural myocardial injury (defined as a peak high sensitivity troponin<br /><br>T of >=0.014ng/mL); descriptive study of IMR measurements in calcified lesions;<br /><br>technical success (defined as a residual stenosis <30% in the presence of TIMI<br /><br>III flow); procedural success (defined as technical success with no in-hospital<br /><br>MACE); in cases where intra-coronary imaging such as OCT is performed:<br /><br>interaction between calcium score and primary endpoint; comparison of stent<br /><br>expansion between the two groups; procedure cost; procedure duration; radiation<br /><br>dose; cross-over to alternative strategy; 30-day and 1-year MACE.</p><br>