A Randomized Controlled Trial Comparing Rates of Peri-procedural Myocardial Infarction After Intravascular Ultrasound and Rotational Atherectomy in Patients With Calcified Coronary Artery Lesions

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
University Hopsitals Leuven
RECRUITING
Leuven
Time Frame
Start Date: 2022-02-04
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 170
Treatments
Active_comparator: Rotablation
Use of rotational atherectomy first-line if NC balloon does not fully open
Active_comparator: Shockwave IVL
Use of Shockwave IVLS first-line if NC balloon does not fully open
Sponsors
Collaborators: Centre Hospitalier Universitaire Saint Pierre, AZ Sint-Lucas Brugge, Hôpital Jolimont, Imelda Hospital, Bonheiden, Universitair Ziekenhuis Brussel, Ziekenhuis Oost-Limburg, University Hospital, Ghent, Ziekenhuis Netwerk Antwerpen (ZNA)
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov

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