ACOART BTK RENEW：A Post Market Clinical Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: DEB catheter

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhuang Baixi; Phone Number: 010-62835122; Email: zhuangbaixi@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Chui Yang Liu Hospital Affiliated to Tsinghua University
      • Contact: Yang Yongjiu; Phone Number: 010-67700622; Email: docyyj@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEB catheter; Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm	Device: DEB catheter; Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse event (MAE) rate	Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR	30 days
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
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
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
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
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
Rate of ulcer healing	Ulcer healed or not; if not, improving, stagnant,worsening	12 months,24 months,36 months,48 months ,60 months
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

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Investigators: Principal Investigator: Zhuang Baixi, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 28, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: ACOART BTK RENEW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No