ACOART BTK RENEW：A Post Market Clinical Study

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease
• Interventions: Device: DEB catheter

• Registration Number: NCT04885985
• Lead Sponsor: Acotec Scientific Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-13
• Study Start: 2021-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Primary Completion: 2024-08-01
• Last Update Posted: 2024-08-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEB catheter	DEB catheter	Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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 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 distal embolization	through procedure completion	Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure

Trial Locations

Locations (1)

Chui Yang Liu Hospital affiliated to Tsinghua University; 🇨🇳 Beijing, Beijing, China