SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study
ConditionCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational Heart Centre Singapore
About this trial
Interventional cardiologists are facing an increasing burden of calcified coronary arteries in keeping with an ageing population and rising prevalence of diabetes mellitus and chronic kidney disease. Heavily calcified plaques impede balloon dilatation and successful stent delivery, resulting stent under-expansion, malposition, and damage to the drug-eluting polymer coats. This translates to poorer procedural outcomes and increased risk of Major Adverse Cardiovascular Events (MACE). The investigators' proposal seeks to determine the feasibility of the SoniCracker IVL in patients with calcified coronary lesions.
Eligibility criteria
Qualifiers
Patients at age ≥ 21 years old.
Patients undergoing elective/ planned PCI with at least moderate coronary calcification on angiography at the target lesion are eligible for enrolment. Moderate coronary calcification is defined as densities on only one side of the arterial wall prior to contrast injection. Severe calcification was defined as radiopacities on both sides of the arterial wall prior to contrast injection.
Patients need to demonstrate evidence of either a 180 arc of coronary calcium or nodular calcium at the target lesion on intravascular imaging prior to IVL therapy.
Disqualifiers
Cardiac arrest
Cardiogenic shock
Collapse / comatose / semi-conscious states
Patients requiring urgent or emergent PCI.
Trial design
Treatments tested in this trial
- Medical device
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
National Heart Centre Singapore
Lead sponsor
Biosensor Interventional Technologies Pte Ltd
Collaborator
Source ClinicalTrials.gov