None listed
Conditions
Brief summary
Coronary calcification complicates the delivery and expansion of stents and is a risk factor for major adverse cardiovascular events such as cardiac death or myocardial infarction. Intravascular lithotripsy (IVL) provides a variation to currently available percutaneous coronary interventions by delivering an acoustic pressure wave within the balloon to modify calcium, and in doing so enhancing vessel accessibility and providing a better environment for stent deployment. IVL has shown safety and effectiveness in multicentre studies, and our study will confirm the benefits of IVL in the context of our local facility for optimising stent implantation in calcified coronary lesions.
Interventions
Intravascular Lithotripsy (IVL) is a technique based on lithotripsy, an established treatment strategy for renal calcification, in which multiple lithotripsy emitters mounted on a traditional balloon catheter platform create diffusive pulsatile mechanical energy to disrupt calcium within the vessel wall at low inflation pressures.
For coronary artery calcification, the recent Disrupt CAD III study reported high rates of device success, safety and performance of coronary IVL in vessel preparatio
Intravascular Lithotripsy (IVL) is a technique based on lithotripsy, an established treatment strategy for renal calcification, in which multiple lithotripsy emitters mounted on a traditional balloon catheter platform create diffusive pulsatile mechanical energy to disrupt calcium within the vessel wall at low inflation pressures. For coronary artery calcification, the recent Disrupt CAD III study reported high rates of device success, safety and performance of coronary IVL in vessel preparation of calcified stenotic coronary lesions prior to stent implantation. The Shockwave Medical (Santa Clara, CA, USA) IVL system and coronary IVL catheter consist of a fluid-filled balloon angioplasty catheter and guidewire. Lithotripsy emitters are housed in the 12mm balloon segment. Each catheter is single use and can deliver a total of 80 IVL pulses. All participants will have the procedure completed by a cardiologist with minimum 5 years experience in other forms of percutaneous coronary intervention who is trained in using the Shockwave IVL. A single IVL intervention will be undertaken in the Mackay Base Hospital Cardiac Catheterisation laboratory. The IVL catheter will be inserted and delivered over guidewire. Atherectomy devices and cutting/scoring balloons will not be used. The IVL balloon will be inflated to 4 atm and 10 IVL pulses will be delivered followed by inflation of the balloon to 6 atm. This will be continued until the balloon has expanded to full capacity, whereby the stent can be implanted. Procedure duration is anticipated to be a mean (+/- SD) of 70 (+/- 30) mins. Patient medical records will be used to monitor adherence to the intervention and patient outcomes.
Sponsors
Mackay Hospital and Health Service
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure or if troponin is elevated, concomitant CK must be normal • The target vessel must have a TIMI flow 3 at baseline • Patients with significant (> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI • Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life • Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery > 50% in a reference vessel of 2.5mm – 4.0 mm diameter and < 32 mm length • Presence of calcification within the lesion on both sides of the vessel as assessed by angiography • Planned treatment of single lesion in one vessel • Ability to pass a 0.014’’ guide wire across the lesion • Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures • Patient is able and willing to comply with all assessments in the study
Exclusion criteria
• Concomitant use of other techniques to deal CAC such as atherectomy and special balloons • Severe renal failure • Severe anaemia • Previous PCI within 30 days of planned procedure • Patients not suitable for consenting such as severe memory impairment • Acute coronary syndrome within 1 month from planned procedure • Severe Heart Failure (NYHA III or IV) • Unable to tolerate dual antiplatelet agents (Aspirin + clopidogrel or ticargrelor or prasugrel) for 1 year for any reason • Contrast allergy • Active infection
Outcome results
None listed