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

Acotec Scientific Co., Ltd1 site in 1 country107 target enrollmentDecember 31, 2021

ConditionsPeripheral Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Acotec Scientific Co., Ltd
Enrollment: 107
Locations: 1
Primary Endpoint: Primary Patency
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 31, 2021

End Date

April 1, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Acotec Scientific Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old and ≤75 years old
•Rutherford clinical category classification：3,4 or 5
•Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
•Reference vessel diameter is between 2 mm and 4 mm
•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

•Plasma creatinine clearance rate \<30 mL/min
•Acute vessel occlusion or acute thrombosis in target lesion
•Planned amputation on the target limb
•Subjects confined to bed that are completely non-ambulatory.
•Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
•Life expectancy \< 5 year.
•Cumulative length of 100% occluded target lesion(s)\>150 mm
•In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
•History of stroke within 90 days prior to enrollment
•Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy

Outcomes

Primary Outcomes

Primary Patency

Time Frame: 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 Outcomes

Rate of All-cause mortality(12 months,24 months,36 months,48 months ,60 months)
Major adverse event (MAE) rate(30 days)
Rate of clinically-driven target vessel revascularization (CD-TVR)(12 months,24 months,36 months,48 months ,60 months)
Patency rate(12 months,24 months,36 months,48 months ,60 months)
Rate of clinically-driven target lesion revascularization (CD-TLR)(12 months,24 months,36 months,48 months ,60 months)
Rate of ulcer healing(12 months,24 months,36 months,48 months ,60 months)
Rate of major target limb amputation(12 months,24 months,36 months,48 months ,60 months)
Rate of distal embolization(through procedure completion)