Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
107 participants
INTERVENTIONAL
2021-12-31
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DEB catheter
Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm
DEB catheter
Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")
Interventions
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DEB catheter
Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Acotec Scientific Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Zhuang Baixi
Role: PRINCIPAL_INVESTIGATOR
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Locations
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Chui Yang Liu Hospital affiliated to Tsinghua University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ACOART BTK RENEW
Identifier Type: -
Identifier Source: org_study_id
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