BASIL Study: A randomised comparison study on the treatment of calcified (hard and concrete-like) coronary artery using the conventional balloon angioplasty prior stenting versus the use of Shockwave Intravascular Lithotripsy (S-IVL) prior to stenting.

Balloon Angioplasty versus Shockwave Intravascular Lithotripsy (S-IVL). Participants enrolled into this Clinical Research will be derived from the general interventional cardiology population. Patients meeting all clinical inclusion criteria and undergoing coronary angiography who are found to have significant calcified coronary stenosis will be eligible to participate in this study at the time of their coronary stent implantation procedure in the cardiac catheter laboratory. The Interventional Cardiologist will deliver the intervention procedure during the patient's scheduled percutaneous coronary intervention (PCI) with the use of either percutaneous coronary angioplasty with coronary stent implantation or with the use of Shockwave Intravascular Lithotripsy (S-IVL) percutaneous coronary angioplasty with coronary stent implantation as per randomisation allocation. Post procedure and hospital discharge monitoring will be performed in the Cardiovascular Unit and or at the Cardiology Ward. Telephone follow-up will be performed 30 days following hospital discharge. A) a brief description of the procedures, including how they differ, Calcified coronary lesions pose challenges for percutaneous coronary intervention (PCI). Aggressive balloon dilatation for lesion preparation may result in unnecessary vessel dissection and vessel trauma. Stent delivery is often more difficult and not uncommonly calcification results in stent under-expansion with reduced final lumen diameter (FLD). There is an association between heavily calcified lesions and subsequent target lesion failure (TLF) and target vessel failure (TVF) Several methods of lesion preparation have been utilised in the past: directional atherectomy, laser atherectomy and transluminal extraction catheters. These have become obsolete. The conventional contemporary lesion preparation is the use of rotational or orbital atherectomy utilizing high-speed rotating burrs or the use of various cutting and scoring balloons designed to disrupt lesion architecture. Whereas there is limited direct clinical outcome benefit for these devices, their ability to enhance stent delivery and optimize expansion and reduce procedural risk indirectly translates into better outcomes. Calcified coronary lesions often cause suboptimal stent expansion, which is one of the greatest predictors of adverse outcomes such as stent thrombosis and restenosis. Shockwave intravascular lithotripsy (S-IVL; Shockwave Medical, Inc) is a recently approved technique used in the treatment of heavily calcified coronary lesions. Shockwave Intravascular lithotripsy (S-IVL) was recently developed for use in coronary lesions. Lithotripsy is delivered when emitters within a delivery balloon generate sonic pressure waves selectively fracturing calcium within the vessel wall resulting in better stent delivery and expansion. Shockwave C2 catheter gained European CE marking in May 2017. It has been proven to be safe with no excess procedural or 30-day negative clinical outcome measures. B) any physical or informational materials used, including a description of any device(s) used: All patients undergoing coronary angiography will be screened for their BASIL Study eligibility and those that have not met any of the clinical exclusion criteria will be invited to participate and will be given the New Zealand Health and Disability Ethics Committee (NZ HDEC) approved participant information sheet and consent form ahead of time prior to their scheduled coronary angiogram procedure. If the patient agrees to participate, clinical study participant information sheet and consent form must be signed and completed by the patient and the BASIL Study Team as delegated by the Principal Investigator. A copy of the completed informed consent form must be provided to the patient and a copy kept on the patient’s medical records including the documentation of the consent process. All patients must be given the opportunity to ask questions about the study and must be given sufficient time to decide to participate in the study or not. The patient is to be made aware that their participation in the study is voluntary and that they may withdraw from the study at any time, without giving specific reason for doing so. The patient must also be informed that withdrawal from the study will not affect their future treatment. The investigator is responsible for the achievement of written consent from the patient before they are included in the study. All patients must provide informed consent in accordance with the NZ HDEC requirements, using an EC-approved informed consent form. Confirmation of patient enrolment status (randomised/included or not randomised/not included) to the BASIL Study following angiographic screening procedures will be given to patients who have signed the participant information sheet and consent form following their coronary angiography procedure and copies filed to subject’s medical file. Shockwave intravascular lithotripsy (S-IVL) manufactured by Shockwave Medical, Inc is a recently approved technique used in the treatment of heavily calcified coronary lesions. C) the approximate duration of the procedure(s). A diagnostic angiogram would normally take from 30 up to 60 minutes. The use of Shockwave Coronary Intravascular Lithotripsy (S-IVL) may take from to 30 to 45 minutes. The total hours involved in percutaneous coronary intervention (PCI) normally takes 90 minutes and up to two hours, although it can take longer.