Chronic Limb-Threatening Ischemia
Conditions
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)
Interventions
Sponsors
Acotec Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- General Inclusion Criteria 1. Age ≥ 18 years at the time of consent; 2. 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; 3. 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); 4. Life expectancy \> 1 year in the Investigator's opinion; 5. Subject presenting with documented chronic limb-threatening ischemia(CLTI) in the target limb defined as Rutherford category 4 or 5; 6. 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; 7. No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment. * Angiographic Inclusion Criteria 8. Reference Vessel Diameter(RVD) ≥2.0 and ≤ 4.0mm and able to be treated with available device size matrix; 9. Total length of target lesion (including significant stenosis 70\ 99% or occlusion) ≤ 190mm; 10. 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; 11. 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; 12. 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; 13. 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.
Exclusion criteria
\- General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: Composite of freedom from major amputation and primary patency | 12 months | 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. |
| Primary Safety Endpoint: Composite of MALE and POD (Major Adverse Limb Event + Peri-Operative Death) | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate | 1, 3, 6, 12, 24, 36 months | 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; |
| Freedom from CD-TLR | 1, 3, 6, 12, 24, 36 months | 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. |
| Re-occlusion rate of target lesion | 1, 3, 6, 12, 24, 36 months | Re-occlusion rate of target lesion as determined by duplex ultrasound(no flow) and/or angiography; |
| Rate of Major adverse events(MAE) | 1, 3, 6, 12, 24, 36 months | MAE is defined as all-cause death, target limb major amputation and CD-TLR; |
| Rate of target limb major amputation | 1, 3, 6, 12, 24, 36, 48, 60 months | Rate of target lmb major amputations at 1, 3, 6, 12, 24, 36, 48 and 60 months; |
| Rate of all-cause death | 1, 3, 6, 12, 24, 36, 48, 60 months | Rate of all-cause death at 1, 3, 6, 12, 24, 36, 48 and 60 months; |
| Amputation free survival rate | 1, 3, 6, 12, 24, 36, 48, 60 months | Amputation free survival rate at 1, 3, 6, 12, 24, 36, 48 and 60 months; |
| Change in ankle-brachial index(ABI) | 1, 3, 6, 12, 24, 36 months | Change in ABI from pre-procedure to 1, 3, 6, 12, 24 and 36 months |
| Change in toe-brachial index(TBI) | 1, 3, 6, 12, 24 months | Change in TBI from pre-procedure to 1, 3, 6, 12 and 24 months |
| Powered Secondary Endpoint: Freedom from clinically driven TLR (CD-TLR) at 12 months | 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) |
| Change in EQ-5D | 1, 3, 6, 12, 24 and 36 months | Change in EQ-5D from pre-procedure to 1,3, 6,12, 24 and 36 months |
| Rate of Technical Success | During the procedure(After using the PCB catheter) | Technical Success is defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter stenosis in the treated lesion on completion angiography |
| Rate of Procedure Success | within 72 hours of the index procedure | Evidence of both acute technical success and absence of safety events(e.g., death, stroke, myocardial infraction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery) within 72 hours of the index procedure |
| Change in VascuQol | 1, 3, 6, 12, 24 and 36 months | Change in VascuQol from pre-procedure to 1,3, 6,12, 24 and 36 months |
| Primary sustained clinical improvement | 1 year | An improvement shift in the Rutherford classification of 1 class in amputation-free, clinically driven TLR-free surviving patients at 1 year |
| Secondary sustained clinical improvement | 1 year | An improvement shift in the Rutherford classification of 1 class including the need for clinically driven TLR in amputation-free surviving patients at 1 year |
| Wound healing | 1, 3, 6, 12, 24 and 36 months | The wound will be evaluated at 1, 3, 6, 12, 24 and 36months |
| Rate of Device Success | During the procedure(After using the PCB catheter) | Device Success is defined as, a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the delivery catheter |
| Change in Rutherford category | 1, 3, 6, 12, 24 and 36 months | Change in Rutherford category from pre-procedure to 1, 3, 6, 12, 24 and 36 months |
| Composite of Limb salvage and primary patency | 1, 3, 12, 24 and 36 months | Composite of limb salvage and primary patency at 1, 3, 12, 24 and 36 months |
Countries
Austria, Belgium, United States
Contacts
Primary ContactLijuan Jenny Wang, PhD
Outcome results
None listed