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AcoArt Litos PCB Below-the-knee Global Trial

Chronic Limb-Threatening Ischemia Clinical Trial

Official title:
Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients With Chronic Limb-Threatening Ischemia

Clinical Trial Summary

The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Chronic Limb-Threatening Ischemia
  • Ischemia
Clinical Trial Details
NCT number NCT06330493
Study type Interventional
Source Acotec Scientific Co., Ltd
Contact
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date December 2030
View Details
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