AcoArt Litos PCB Below-the-knee Global Trial
ConditionChronic Limb-Threatening Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcotec Scientific Co., Ltd
About this 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 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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
PCB
DevicePaclitaxel coated PTA balloon catheter
PTA
DeviceNon-coated FDA cleared (US) or CE-marked (EU) standard percutaneous transluminal angioplasty balloon catheter
Treatment groups
288 Participants
are divided into 2 treatment groupsGroup A: PCB GroupExperimental treatment 1 intervention
Group B: PTA GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
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.
Time frame
30 daysSecondary outcomes
1
Powered Secondary Endpoint: Freedom from clinically driven TLR (CD-TLR) at 12 months
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR)
Time frame
12 months2
Composite of Limb salvage and primary patency
Composite of limb salvage and primary patency at 1, 3, 12, 24 and 36 months
Time frame
1, 3, 12, 24 and 36 months3
Patency rate
Patency rate is defined as the absence of target lesion occlusion(flow/no flow) as determined by duplex ultrasound and/or angiography and freedom from clinically-driven TLR;
Time frame
1, 3, 6, 12, 24, 36 months4
Freedom from CD-TLR
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.
Time frame
1, 3, 6, 12, 24, 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov