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ACOART BTK RENEW：A Post Market Clinical Study

ConditionPeripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAcotec Scientific Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • DEB catheter

    Device

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

Treatment groups

107 Participants
are divided into 1 treatment group
Group A: DEB catheterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 month

Secondary outcomes

1

Major adverse event (MAE) rate

Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR

Time frame
30 days
2

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.

Time frame
12 months,24 months,36 months,48 months ,60 months
3

Rate of major target limb amputation

A major adverse limb event is defined as above-ankle amputation of the treated limb

Time frame
12 months,24 months,36 months,48 months ,60 months
4

Rate of All-cause mortality

All-cause mortality at 12, 24, 36, 48, 60 months post procedure

Time frame
12 months,24 months,36 months,48 months ,60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acotec Scientific Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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