AcoArt Litos PCB Below-the-knee Global Trial

Part of paid clinical trials in Hialeah, Florida.

Sponsor
Acotec Scientific Co., Ltd
Study ID
NCT06330493
Status
Recruiting
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Conditions

  • Chronic Limb-Threatening Ischemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PCB — DEVICE
    Paclitaxel coated PTA balloon catheter
  • PTA — DEVICE
    Non-coated FDA cleared (US) or CE-marked (EU) standard percutaneous transluminal angioplasty balloon catheter

Study Details

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)

Key Dates

Start date
Oct 10, 2024
Status verified
Mar 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2032

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PCB Group
    use PCB catheter(trade name: AcoArt Litos) to treat the stenosis or occlusion in infrapopliteal artery of experimental arm
  • Active Comparator: PTA Group
    use standard PTA balloon catheter to treat stenosis or occlusion in infrapopliteal artery of control group

Primary Outcome Measure

Primary Efficacy Endpoint: Composite of freedom from major amputation and primary patency [ Time Frame: 12 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Miami Vascular CenterHialeahFlorida33012
Keyttia Sardinas, Clinical Research Coordinator
305-822-0068
Pablo Guala, MD (PRINCIPAL_INVESTIGATOR)
First Coast Cardiovascular InstituteJacksonvilleFlorida32255
Amy Suphachinda, Clinical Research Manager
(904) 493-3333
Yazan Khatib, MD (PRINCIPAL_INVESTIGATOR)
Midwest Cardiovascular Research FoundationDavenportIowa52801
Gail Shammas
[email protected]
563-324-2828
Nicolas Shammas, MD, MS, EJD, FACC, FSCAI, FICA (PRINCIPAL_INVESTIGATOR)
Columbia University/NYPHNew YorkNew York10032
Kate Dalton
[email protected]
347-514-3366
Sahil Parikh, MD, PhD (PRINCIPAL_INVESTIGATOR)
South Charlotte General & Vascular SurgeryCharlotteNorth Carolina28278
Alexis LeMieux, Clinical Research Coordinator
253-307-6290
James Antezana, MD (PRINCIPAL_INVESTIGATOR)
Miriam HospitalProvidenceRhode Island02906-
Clements University Hospital (UTSW)DallasTexas75390
Vernell Sparks, Clinical Research Manager
Michael Siah, MD (PRINCIPAL_INVESTIGATOR)
Sunrise VascularDanvilleVirginia24541
Alexis LeMieux, Clinical Research Coordinator
(253) 307-6290
Sreejit Nair, MD (PRINCIPAL_INVESTIGATOR)

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