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Study identifier: NCT06330493 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

AcoArt Litos PCB Below-the-knee Global Trial

Condition: Chronic Limb-Threatening Ischemia  ·  Sponsor: Acotec Scientific Co., Ltd

PhaseNA
Planned participants288
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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)

This description comes directly from the study's public registry record.

Talk to the study team

Kris Kelker  ·  408-398-3784  ·  Kris.kelker@acotec.com

Always discuss trial participation with your own doctor first.

Locations (19)

John Muir HealthConcord, California, United StatesRecruiting
California Cardiovascular Consultants and Medical AssociatesFremont, California, United StatesRecruiting
Yale School of MedicineNew Haven, Connecticut, United StatesRecruiting
Miami Vascular CenterHialeah, Florida, United StatesRecruiting
First Coast Cardiovascular InstituteJacksonville, Florida, United StatesRecruiting
Midwest Cardiovascular Research FoundationDavenport, Iowa, United StatesWithdrawn
American Endovascular and Amputation Prevention (AEAP)Orange, New Jersey, United StatesRecruiting
Columbia University/NYPHNew York, New York, United StatesRecruiting
Cornell UniversityNew York, New York, United StatesRecruiting
South Charlotte General & Vascular SurgeryCharlotte, North Carolina, United StatesRecruiting
Cleveland ClinicCleveland, Ohio, United StatesRecruiting
Miriam HospitalProvidence, Rhode Island, United StatesRecruiting

+ 7 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06330493