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Recruiting NCT04885985

ACOART BTK RENEW：A Post Market Clinical Study

No phase Interventional Peripheral Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DEB catheter.
Who it may be relevant to
Registry conditions: Peripheral Artery Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Primary Patency [Time frame: 6 month]
Secondary outcome measures (8)
  • Major adverse event (MAE) rate [Time frame: 30 days]
  • Patency rate [Time frame: 12 months,24 months,36 months,48 months ,60 months]
  • Rate of major target limb amputation [Time frame: 12 months,24 months,36 months,48 months ,60 months]
  • Rate of All-cause mortality [Time frame: 12 months,24 months,36 months,48 months ,60 months]
  • Rate of clinically-driven target vessel revascularization (CD-TVR) [Time frame: 12 months,24 months,36 months,48 months ,60 months]
  • Rate of clinically-driven target lesion revascularization (CD-TLR) [Time frame: 12 months,24 months,36 months,48 months ,60 months]
  • Rate of ulcer healing [Time frame: 12 months,24 months,36 months,48 months ,60 months]
  • Rate of distal embolization [Time frame: through procedure completion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chui Yang Liu Hospital affiliated to Tsinghua University — Beijing

Identifiers

NCT: NCT04885985 · ACOART BTK RENEW

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗