Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)

"Device:~Neurovascular Intravascular Shockwave Catheter (single-use, rapid-exchange balloon catheter with integrated shockwave emitters).~Intravascular Shockwave Therapy Device (IVL-HVG-N01, generates localized shockwaves to fracture calcifications).~Procedure:~Patients undergo standard CAS preparation with guidewire placement and cerebral protection.~If conventional balloon angioplasty fails (residual stenosis \>70%), the IVL catheter is advanced to the target lesion.~Shockwave therapy is applied at 6 atm, followed by low-pressure balloon dilation (8 atm) if needed.~Subsequent stent deployment is performed per standard practice."