We have located links that may give you full text access.
Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses.
Journal of Endovascular Therapy 2018 August
PURPOSE: To evaluate the safety and feasibility of treating calcified infrapopliteal stenoses using an intravascular lithotripsy (IVL) system.
METHODS: The Disrupt BTK study was a prospective, nonrandomized, multicenter, feasibility, and safety trial that enrolled 20 patients (mean age 79.0±9.6 years; 14 men) at 3 participating sites ( ClinicalTrials.gov identifier NCT02911623). Fifteen patients had Rutherford category 5 ischemia, and all patients had moderate to severe below-the-knee arterial calcification. Patients were treated with the Shockwave Medical Peripheral IVL System and followed for 30 days. The primary safety endpoint was a composite of major adverse events through 30 days defined as death, myocardial infarction, need for emergency surgical revascularization of the target limb, or amputation of the target limb. The primary effectiveness outcome was acute reduction in the percent diameter stenosis.
RESULTS: IVL catheter delivery was successful in 19 patients. The composite of major adverse events at 30 days was 0%. The acute reduction in percent diameter stenosis of target lesions was 46.5%. All patients achieved residual diameter stenosis ≤50%. Vascular complications were minimal with only 1 type B dissection reported and 2 stents placed. None of the subjects experienced thrombus formation, abrupt closure, distal embolization, or perforation. There were no device-related complications.
CONCLUSION: The early results of this pilot study demonstrated that calcified, stenotic infrapopliteal arteries can be safely and successfully treated with intravascular lithotripsy.
METHODS: The Disrupt BTK study was a prospective, nonrandomized, multicenter, feasibility, and safety trial that enrolled 20 patients (mean age 79.0±9.6 years; 14 men) at 3 participating sites ( ClinicalTrials.gov identifier NCT02911623). Fifteen patients had Rutherford category 5 ischemia, and all patients had moderate to severe below-the-knee arterial calcification. Patients were treated with the Shockwave Medical Peripheral IVL System and followed for 30 days. The primary safety endpoint was a composite of major adverse events through 30 days defined as death, myocardial infarction, need for emergency surgical revascularization of the target limb, or amputation of the target limb. The primary effectiveness outcome was acute reduction in the percent diameter stenosis.
RESULTS: IVL catheter delivery was successful in 19 patients. The composite of major adverse events at 30 days was 0%. The acute reduction in percent diameter stenosis of target lesions was 46.5%. All patients achieved residual diameter stenosis ≤50%. Vascular complications were minimal with only 1 type B dissection reported and 2 stents placed. None of the subjects experienced thrombus formation, abrupt closure, distal embolization, or perforation. There were no device-related complications.
CONCLUSION: The early results of this pilot study demonstrated that calcified, stenotic infrapopliteal arteries can be safely and successfully treated with intravascular lithotripsy.
Full text links
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app