Clinical Trial TitleProspective, Multi-Center, Single-arm study of the shockwave medical peripheral intravascular lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
National Clinical Trial Number:NCT05007925
Clinical Trial Protocol Description:
Study for patients with moderate to severe calcified peripheral artery disease below the knee presenting with Rutherford Category (RC) 3 to 5 to determine the safety and effectiveness of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Total study participation will be approximately 48 months.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Present with Rutherford 3, 4, or 5 in target limb.
- Present with 2 below-the-knee target lesions in native vessels on both limbs.
You will be excluded from the study if any of the following criteria apply to you:
- Have had endovascular or surgery on the target limb within 30 days
- Are on antiplatelet or anticoagulant therapy.
- Have presence of acute or chronic renal disease.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.