Clinical trial NCT05208749: ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial
Official title: A Randomized Controlled Trial Comparing Rates of Peri-procedural Myocardial Infarction After Intravascular Ultrasound and Rotational Atherectomy in Patients With Calcified Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Calcified Atheroma
Coronary Artery Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: University Hospital, Ghent
name: Universitair Ziekenhuis Brussel
name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: Imelda Hospital, Bonheiden
name: AZ Sint-Lucas Brugge
name: Centre Hospitalier Universitaire Saint Pierre
name: Hôpital Jolimont
First posted: 2022-01-26
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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). The mechanism of PPMI is thought to be related to side branch occlusion, coronary artery dissection and acute microvascular damage caused by embolization of plaque debris during the PCI and is more frequently seen in calcified coronary artery disease. Calcium modification by rotational atherectomy (RA) results in peri-procedural myocardial infarction in 24% of cases and myocardial injury in 70% of cases. The Shockwave coronary intravascular lithotripsy (IVL) balloon catheter emits sonic pressure waves in a circumferential field causing the selective fracture of calcium, altering vessel compliance and permitting further expansion of the vessel wall. This provides a potentially safer alternative to other calcium-modifying devices since there is a low risk of dissection and perforation. It is also proposed that this IVL device reduces the risk of atheromatous embolization, which would reduce the risk of PPMI and microvascular dysfunction. The SONAR Trial is a pilot study measuring peri-procedural myocardial injury, PPMI and microvascular dysfunction in patients (with calcified coronary artery lesions not responding to usual balloon dilatation) randomized to RA or Shockwave IVL. The primary outcome is peri-procedural myocardial infarction. Secondary outcomes include peri-procedural myocardial injury, acute microvascular dysfunction, procedural success, and procedural costs.

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 PCI in 170 patients (85 per arm) treated with Shockwave intravascular lithotripsy (IVL) versus RA. Patients with moderately and/or severely calcified coronary lesions, which are equally suitable for IVL and RA and do not dilate fully (100%) with an appropriately sized non-compliant balloon at 16 atmospheres, will be recruited. The calcified lesion must be suitable for both IVL and RA and the operator believes that either IVL or RA could be used. The primary outcome will be difference in the rate of peri-procedural myocardial infarction (Type 4a of the universal Definition of Myocardial Infarction). Peri-procedural myocardial injury and infarction will be defined by an increase in high-sensitivity Troponin T according to the Fourth Universal Definition of Myocardial Infarction,15 while microvascular dysfunction will be defined by an Index of Microcirculatory Resistance (IMR) of ≥25.16 Patients will undergo study-related clinical follow up at 30 days and 12 months.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Difference in peri-procedural myocardial infarction (Type 4a)
timeFrame: within 24 hours of index PCI
Secondary outcomes:
measure: Procedural differences (technical and procedural success, procedural characteristics and costs).
timeFrame: periprocedural
measure: Difference in change in IMR between the two groups.
timeFrame: periprocedural
measure: Clinical outcomes at 30-days and 1 year.
timeFrame: 1 year
measure: IMR change post-PCI in calcified lesions
timeFrame: periprocedural
measure: Peri-procedural myocardial injury incidence
timeFrame: periprocedural
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hopsitals Leuven
state: Brabant
Study officials:
References: