AcoArt Litos PCB Below-the-knee Global Trial

NCT06330493 | Recruiting FDA Device

• 1 other identifier: AcoArt BTK Global Trial
• Study Type: interventional
• Target: 288
• Locations: 3 countries
• Sites: 10

Brief 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)

Conditions

Chronic Limb-Threatening Ischemia

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: Composite of freedom from major amputation and primary patency

  Composite of freedom from major amputation (above ankle amputation) and primary patency at 6 months. Primary patency is defined as absence of target lesion occlusion (no flow) and/or target lesion binary restenosis as determined by duplex ultrasound or angiography and/or clinically driven target lesion revascularization (CD-TLR). Binary restenosis is defined as the presence of target lesion with a hemodynamically significant restenosis ≥ 50% by angiography or PSVR ≥ 2.4 by duplex ultrasound. CD-TLR is defined as revascularization due to restenosis of ≥ 70% in the target lesion and * Wound persistence and/or; * Increase in size of pre-existing wounds and/or; * Occurrence of new wounds and/or; * Deterioration of Rutherford Class; * Hemodynamic change: decrease in TBI of 0.15 or more.

  12 months

• Primary Safety Endpoint: Composite of MALE and POD (Major Adverse Limb Event + Peri-Operative Death)

  Major adverse limb event (MALE, defined as the composite of above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery) and perioperative death (POD) at 30 days.

  30 days

Secondary Outcomes (20)

• Powered Secondary Endpoint: Freedom from clinically driven TLR (CD-TLR) at 12 months

  12 months

• Composite of Limb salvage and primary patency

  1, 3, 12, 24 and 36 months

• Patency rate

  1, 3, 6, 12, 24, 36 months

• Freedom from CD-TLR

  1, 3, 6, 12, 24, 36 months

• Re-occlusion rate of target lesion

  1, 3, 6, 12, 24, 36 months

Study Arms (2)

PCB Group

EXPERIMENTAL

use PCB catheter(trade name: AcoArt Litos) to treat the stenosis or occlusion in infrapopliteal artery of experimental arm

Device: PCB

PTA Group

ACTIVE COMPARATOR

use standard PTA balloon catheter to treat stenosis or occlusion in infrapopliteal artery of control group

Device: PTA

Interventions

PCB DEVICE

Paclitaxel coated PTA balloon catheter

Also known as: AcoArt Litos PCB

PCB Group

PTA DEVICE

Non-coated FDA cleared (US) or CE-marked (EU) standard percutaneous transluminal angioplasty balloon catheter

PTA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of consent;
• Subjects has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Institutional Review Board(IRB)/Ethics Commitee(EC) approved consent form;
• Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses);
• Life expectancy \> 1 year in the Investigator's opinion;
• Subject presenting with documented chronic limb-threatening ischemia(CLTI) in the target limb defined as Rutherford category 4 or 5;
• In case of Rutherford category 5: Subjects with documented wound score 0-1, infection grade 0-2 and ischemia grade 2-3 according to the wound ischemia foot infection (WIfI) classification;
• No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.
• Reference Vessel Diameter(RVD) ≥2.0 and ≤ 4.0mm and able to be treated with available device size matrix;
• Total length of target lesion (including significant stenosis 70\~99% or occlusion) ≤ 190mm;
• The lesion must be located in the infrapopliteal arteries and above the ankle joint. Lesions may not extend proximal to the P3 segment of the popliteal artery indicated by the tibial plateau or below the tibiotalar joint(arteries of the foot). The treatment(investigational device or PTA, including pre-dilatation) may not extend beyond these indicated regions for more than 1cm;
• Presence of documented run-off to the foot(clearly visible at least one of the following run-off vessels; dorsalis pedis or pedal arch or plantar arteries by angiography). The target vessels should give direct or indirect run-off to the foot;
• Absence of flow-limiting(≥ 50% stenosis) in-flow lesions confirmed by angiography. Patients with flow-limiting inflow lesions can be included if the lesion(s) have been treated successfully before enrollment, with a maximum residual restenosis of ≤30% per visual assessment. If an inflow lesion must be treated within or proximal to the P3 segment of the popliteal artery, there must be a minimum of 3 cm healthy vascular segment between this(treated) lesion and the infrapopliteal target lesion;
• Successful pre-dilatation of the(entire) target lesion. Success being documented by angiographic visual estimate of ≤ 50% residual diameter stenosis of the target lesion and no flow limiting dissection(\< Grade D dissection). Target lesion is not considered non-dilatable by the operator due to concentric, circumferential calcium and target lesion can be treated successfully by balloon angioplasty without the need for bail-out stenting.

You may not qualify if:

• Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre- or post-procedure. A planed amputation including and below the metatarsal level(1 or multiple rays) is accepted.
• Recent MI or stroke \< 30 days prior to the index procedure;
• Known or suspected active infection at the time of the index procedure(abnormal white blood cell count, fever, sepsis, or positive blood culture), with the exception of a localized, controlled infection of a lower extremity wound on the target limb(only WIfI infection grade 0-2 allowed);
• Subjects with infection grade 3 and ischemia grade 0 and 1 according to WIfI classification;
• Subjects not independently ambulating.
• Subjects with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation; Subjects with uncomplicated ulcers can be included;
• Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement;
• Subjects with vasculitis, systemic Lupus Erythematosus or polymyalgia rheumatica on active treatment;
• Subjects with impaired renal function defined as eGFR \<30 ml/min or on dialysis;
• Patient receiving systemic corticosyeroid therapy(expected dosage exceeding 5 mg of prednisolone or equivalent, per day, during the initial 9 months after procedure);
• Known allergies or sensitivities to heparin, aspirin(ASA), other anticoagulant/anti-platelet therapies which could not be substitued, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure;
• Subjects currently enrolled in another investigational device, drug, or biological trial;
• Femal subjects who are breast feeding at the time of enrollment;
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;
• Any severe medical comorbidities(e.g., untreated CAD/CHF, NYHA class IV heart failure, Left Ventricular ejection fraction(LVEF) \</= 30%(obtained within 1 month of index procedure), severe COPD, metastatic malignacy, etc.) that would preclude compliance with the study protocol or currently receiving immune-suppressive, chemotherapeutic, or radiation therapy;

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead

Study Sites (10)

Miami Vascular Center

Hialeah, Florida, 33012, United States

RECRUITING

First Coast Cardiovascular Institute

Jacksonville, Florida, 32255, United States

RECRUITING

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52801, United States

RECRUITING

Columbia University/NYPH

New York, New York, 10032, United States

RECRUITING

South Charlotte General & Vascular Surgery

Charlotte, North Carolina, 28278, United States

RECRUITING

Miriam Hospital

Providence, Rhode Island, 02906, United States

SUSPENDED

Clements University Hospital (UTSW)

Dallas, Texas, 75390, United States

RECRUITING

Sunrise Vascular

Danville, Virginia, 24541, United States

RECRUITING

Medical University Graz

Graz, 8036, Austria

RECRUITING

AZ Sint Blasius Hospital

Dendermonde, Belgium

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Peter Schneider, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sahil Parikh, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Thomas Zeller, MD, PhD

  University of Herzzentrum Freiburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijuan Jenny Wang, PhD

CONTACT

650-284-8296; Jenny.Wang@acotec.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 26, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: July 3, 2025

Record last verified: 2025-03

Locations

US (8); AU (1); BE (1)