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.
Parallel
Intravascular Lithotripsy
Devicestudy group will receive the investigational devices (Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy Device) for calcified lesion pre-treatment.
Rotational Atherectomy
Devicecontrol group will receive the control device (Coronary Rotational Atherectomy System)
Rate of Device Success
Freedom from Major Adverse Cardiovascular Events (MACE) within 30 days post-procedure
Rate of Technical Success
Rate of Angiographic Success
Rate of Procedural Success
Incidence of serious angiographic complications
Quantitative Coronary Angiography (QCA) Subgroup
Optical Coherence Tomography (OCT) Subgroup
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This trial is not recruiting at the moment. You can still explore other options:
