Peripheral Artery Disease
Conditions
Brief summary
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
Interventions
DEVICEDEB catheter
Trade name of DEB catheter: AcoArt Tulip (0.018) or AcoArt Litos (0.014)
Sponsors
Acotec Scientific Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Age ≥18 years old and ≤75 years old * 2\. Rutherford clinical category classification：3,4 or 5 * 3\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent. * 4\. Reference vessel diameter is between 2 mm and 4 mm * 5\. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
Exclusion criteria
* 1\. Plasma creatinine clearance rate \<30 mL/min * 2\. Acute vessel occlusion or acute thrombosis in target lesion * 3\. Planned amputation on the target limb * 4\. Subjects confined to bed that are completely non-ambulatory. * 5\. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment. * 6\. Life expectancy \< 5 year. * 7\. Cumulative length of 100% occluded target lesion(s)\>150 mm * 8\. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm * 9\. History of stroke within 90 days prior to enrollment * 10\. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy * 11\. Uncorrectable bleeding diathesis * 12\. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery * 13\. Pregnant or breastfeeding female subjects * 14\. Ability to cross a guidewire through target lesion * 15\. Patients who have participated in clinical trials of other medical devices or drugs during the same period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 6 month | Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate | 12 months,24 months,36 months,48 months ,60 months | Defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation. |
| Rate of major target limb amputation | 12 months,24 months,36 months,48 months ,60 months | A major adverse limb event is defined as above-ankle amputation of the treated limb |
| Rate of All-cause mortality | 12 months,24 months,36 months,48 months ,60 months | All-cause mortality at 12, 24, 36, 48, 60 months post procedure |
| Major adverse event (MAE) rate | 30 days | Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR |
| Rate of clinically-driven target lesion revascularization (CD-TLR) | 12 months,24 months,36 months,48 months ,60 months | Clinically-driven target lesion revascularization (CD-TLR) at 12, 24, 36, 48, 60 months post procedure |
| Rate of ulcer healing | 12 months,24 months,36 months,48 months ,60 months | Ulcer healed or not; if not, improving, stagnant,worsening |
| Rate of distal embolization | through procedure completion | Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure |
| Rate of clinically-driven target vessel revascularization (CD-TVR) | 12 months,24 months,36 months,48 months ,60 months | Clinically-driven target vessel revascularization (CD-TVR) at 12, 24, 36, 48, 60 months post procedure |
Countries
China
Contacts
Primary ContactZhuang Baixi
Outcome results
None listed