NCT05208749: SONAR

ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial

Recruiting now NA Last updated 3 July 2024

What this trial tests

NA trial testing Rotablation of shockwave in Calcified Atheroma in 170 participants. Currently enrolling.

Timeline

4 February 2022

Primary endpoint
1 January 2025

1 January 2025

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	170
Start date	4 February 2022
Primary completion	1 January 2025
Estimated completion	1 January 2025
Sites	1 location across Belgium

Drugs / interventions tested

• Rotablation of shockwave

Conditions studied

• Calcified Atheroma — all drugs for Calcified Atheroma →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

18 and older, any sex, with Calcified Atheroma or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions.
   Riley RF, Patel MP, Abbott JD, Bangalore S, et al · · 2024 · cited 58× · PMID 39132214 · DOI 10.1016/j.jscai.2023.101259
2. ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial.
   Bennett J, McCutcheon K, Ameloot K, Vanhaverbeke M, et al · · 2024 · cited 3× · PMID 37714726 · DOI 10.1016/j.carrev.2023.08.019
3. Advances in Technology and Technique in Percutaneous Coronary Intervention: A Clinical Review.
   Saito Y, Kobayashi Y. · · 2026 · cited 1× · PMID 39343561 · DOI 10.2169/internalmedicine.4505-24
4. The Significance of Coronary Artery Calcification for Percutaneous Coronary Interventions.
   Lis P, Rajzer M, Klima Ł. · · 2024 · cited 1× · PMID 38470631 · DOI 10.3390/healthcare12050520
5. Intravascular lithotripsy versus rotational atherectomy for coronary atherosclerosis calcification: a systematic review and meta-analysis.
   Baravia PA, Qhabibi FR, Firdaus I. · · 2026 · PMID 42166042 · DOI 10.1186/s43044-026-00747-2
6. Treating Women With Calcified Coronary Arteries Using Intravascular Lithotripsy: Primary Results of the EMPOWER CAD Study.
   McEntegart M, Gonzalo N, Shlofmitz R, Gunasekaran P, et al · · 2026 · PMID 41868771 · DOI 10.1016/j.jscai.2025.104191