ACOART BTK RENEW：A Post Market Clinical Study

Peripheral Artery Disease Clinical Trial

Official title:

A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885985
• Other study ID #: ACOART BTK RENEW
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2023
• Source: Acotec Scientific Co., Ltd
• Contact: Zhuang Baixi
• Phone: 010-62835122
• Email: zhuangbaixi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 107
• Est. completion date: April 1, 2027
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• DEB catheter
Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")

Locations

Country	Name	City	State
China	Chui Yang Liu Hospital affiliated to Tsinghua University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency	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.	6 month
Secondary	Major adverse event (MAE) rate	Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR	30 days
Secondary	Patency rate	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.	12 months,24 months,36 months,48 months ,60 months
Secondary	Rate of major target limb amputation	A major adverse limb event is defined as above-ankle amputation of the treated limb	12 months,24 months,36 months,48 months ,60 months
Secondary	Rate of All-cause mortality	All-cause mortality at 12, 24, 36, 48, 60 months post procedure	12 months,24 months,36 months,48 months ,60 months
Secondary	Rate of clinically-driven target vessel revascularization (CD-TVR)	Clinically-driven target vessel revascularization (CD-TVR) at 12, 24, 36, 48, 60 months post procedure	12 months,24 months,36 months,48 months ,60 months
Secondary	Rate of clinically-driven target lesion revascularization (CD-TLR)	Clinically-driven target lesion revascularization (CD-TLR) at 12, 24, 36, 48, 60 months post procedure	12 months,24 months,36 months,48 months ,60 months
Secondary	Rate of ulcer healing	Ulcer healed or not; if not, improving, stagnant,worsening	12 months,24 months,36 months,48 months ,60 months
Secondary	Rate of distal embolization	Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure	through procedure completion