AcoArt Litos PCB for Critical Limb Ischemia

Recruiting at 9 trial locations

Overseen By Lijuan Jenny Wang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Acotec Scientific Co., Ltd

Must not be taking: Corticosteroids, Anticoagulants, Antiplatelets, others

Disqualifiers: Recent MI, Stroke, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 61

Duration: During the procedure

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AcoArt Litos PCB, a special catheter designed to open blocked arteries below the knee. Researchers compare it to a standard balloon catheter to determine if it is more effective and equally safe. The trial focuses on aiding individuals with chronic limb-threatening ischemia, a condition where severely reduced blood flow to the legs can cause severe pain or wounds. Individuals with ongoing blood flow issues in their legs who have not undergone surgery or other vascular procedures in the last two weeks may be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to important research that could enhance treatment options for chronic limb-threatening ischemia.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroid therapy or have allergies to certain medications like heparin or aspirin that cannot be substituted, you may not be eligible to participate.

What prior data suggests that the AcoArt Litos PCB device is safe for treating obstructions in the infrapopliteal arteries?

Research has shown that the AcoArt Litos PCB, a specialized balloon for blood vessels, is safe for treating blockages in certain leg arteries. One study found that patients experienced fewer serious problems with the AcoArt Litos PCB than with a regular balloon. Specifically, 34.5% of patients had major issues with the drug-coated balloon, compared to 56.1% with the regular balloon.

Another study found the AcoArt Litos PCB to be safe and effective, showing better results in both scans and patient health. These findings suggest that the AcoArt Litos PCB is generally well-tolerated by patients with similar artery issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AcoArt Litos PCB catheter because it offers a unique approach to treating stenosis or occlusion in the infrapopliteal artery, a condition often managed using standard PTA balloon catheters. Unlike traditional methods, the AcoArt Litos PCB catheter uses a paclitaxel-coated balloon, which delivers a drug directly to the artery wall during the procedure. This drug-coated balloon could potentially improve outcomes by reducing artery re-narrowing, offering a longer-lasting solution compared to regular balloon angioplasty. This innovative method could mean fewer repeat procedures and better long-term results for patients.

What evidence suggests that the AcoArt Litos PCB is effective for treating obstructions in the infrapopliteal arteries?

This trial will compare the effectiveness of the AcoArt Litos PCB catheter with a standard PTA balloon catheter for treating blockages in the lower leg arteries. Research has shown that the AcoArt Litos PCB catheter effectively treats blockages, with studies finding improved long-term survival rates for patients with severe blood flow problems in the legs, known as chronic limb-threatening ischemia (CLTI), compared to traditional methods. Specifically, the AcoArt-BTK trial showed that this drug-coated balloon (DCB) helps keep blood vessels open and improves overall health outcomes. Patients treated with the Litos DCB experienced better blood flow and fewer complications over time. Overall, the AcoArt Litos PCB has shown promising results in helping patients with serious artery blockages in the lower leg. ^{1 2 3 6 7}

Who Is on the Research Team?

Sahil Parikh, MD, PhD

Principal Investigator

Columbia University

Thomas Zeller, MD, PhD

Principal Investigator

University of Herzzentrum Freiburg

Peter Schneider, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

I meet the basic requirements to participate in the trial.

I am not pregnant, can use birth control during the study, or I cannot become pregnant due to medical reasons.

My leg has severe circulation problems, classified as Rutherford 4 or 5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the AcoArt Litos PCB or a standard PTA balloon catheter to treat stenosis or occlusion in the infrapopliteal artery

During the procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of major adverse limb events and perioperative death at 30 days, and various secondary outcomes up to 60 months

60 months

Multiple visits over 60 months

What Are the Treatments Tested in This Trial?

Interventions

• PCB
• PTA

How Is the Trial Designed?

Group I: PCB Group Experimental Treatment 1 Intervention

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

Group II: PTA Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Acotec Scientific Co., Ltd

Lead Sponsor

Trials

17

Recruited

5,800+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39692034/

Long-term Outcomes of the AcoArt II-BTK Trial: Drug ... Infrapopliteal artery revascularization in patients with CLI using Litos/Tulip DCB angioplasty showed superior 5-year overall survival compared with PTA.

2. trialstoday.org trialstoday.org/list/print/NCT06330493

AcoArt Litos PCB Below-the-knee Global Trial PCB Group, use PCB catheter(trade name: AcoArt Litos) to treat the stenosis or occlusion in infrapopliteal artery of experimental arm. Device: ...

3. acc.org acc.org/latest-in-cardiology/clinical-trials/2020/12/31/21/42/acoart-btk

Evaluation of the Use of ACOTEC Drug-Eluting Balloon ... The ACOART-BTK trial showed that use of Litos DCB was superior to balloon angioplasty alone for angiographic and clinical outcomes among patients with CLI and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33118432/

Drug-Coated Balloon Angioplasty Compared With ... This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes.

5. jacc.org jacc.org/doi/10.1016/j.jcin.2020.06.045

Randomized Controlled Trial of Acotec Drug-Eluting ... The data from the ACOART-BTK study demonstrated that the Litos DCB improves vessel patency compared with POBA at 6-month follow-up in a ...

6. researchgate.net researchgate.net/publication/387186664_Long-term_Outcomes_of_the_AcoArt_II-BTK_Trial_Drug-Coated_Balloon_Angioplasty_Compared_With_Uncoated_Balloons_for_the_Treatment_of_Infrapopliteal_Artery_Lesions

Long-term Outcomes of the AcoArt II-BTK Trial The rate of composite major adverse events was 34.5% for DCB angioplasty and 56.1% for PTA (log-rank p=0.013), and this statistically ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06330493/acoart-litos-pcb-below-the-knee-global-trial

AcoArt Litos PCB Below-the-knee Global Trial 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 ...