Safety and Performance of the Coronary Intravascular Lithotripsy (IVL) Technology System
A prospective multi-center, single arm trial designed to demonstrate the safety
and performance of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in
the treatment of calcified coronary artery disease. The study enrolled 60
patients from seven hospitals with a clinical indication for revascularization, a
diameter stenosis ≥50% and lesion length ≤32 mm in native coronary arteries,
with heavy calcification.
The trial was managed with 100% source document verification and with
independent angiographic and optical coherence tomography core labs as
wells as an independent clinical events committee.
To learn more about the trial please visit: DISRUPT CAD: Safety and Performance Trial of the
Shockwave Coronary IVL System.
The study demonstrated compelling safety and performance results with the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in the treatment of patients with heavily calcified coronary arteries. IVL treatment was highly effective facilitating the delivery of stents and reducing restenosis. Stent deployment was performed in 100% of the patients with reduction in residual stenosis to less than 50% in all patients despite >90% of patients having moderate or severe calcification. There were no major intra-procedural complications including perforation, embolization, slow-flow or no reflow and a low MACE rate out to 6 months.
The clinical success rate was achieved in 57 (95.0%) patients, limited only by 3 (5%) asymptomatic non-Q-wave MI. IVL catheter delivery and treatment at the target lesion was successful in 59 (98.3%) patients and stent delivery was successfully completed in all patients.
Primary Performance Outcomes
Primary Safety Outcomes
Consistent, reproducible luminal gain, with an average inflation of 6 atms. No patient required further lesion preparation following Intravascular Lithotripsy (IVL) to deliver and deploy stents. In two patients (3.3%), Grade D dissections were identified post-IVL both of which were resolved with stenting without further clinical sequalae.
Intravascular Lithotripsy (IVL) treatment of calcified coronary arteries addresses
limitations of current options by utilizing a standard technique and devices
utilized in PCI procedures.