The FORWARD IVL trial is a Prospective, Multicenter Study conducted to assess the safety and effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy Device for the pre-treatment of calcified, stenotic de novo coronary artery lesions .
1) Age ≥18 years, male or female.
Target lesion is de novo calcified stenotic coronary lesion with no prior intervention.
Target lesion reference vessel diameter is 2.5-4.0 mm.
Guidewire positioned in the true lumen distal to the target lesion and not in the subintimal space prior to device use.
1) Planning use of scoring/cutting balloons, Excimer Laser Coronary Atherectomy (ELCA), or Coronary Intravascular Lithotripsy balloons for calcified lesion modification prior to study device use.
Unprotected left main coronary artery disease (stenosis >50%).
Serious angiographic complication in the target vessel prior to study device use.
Presence of thrombus or suspected thrombus in the target vessel.