A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion
1 other identifier
interventional
202
1 country
20
Brief Summary
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Typical duration for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJune 13, 2022
March 1, 2022
1.8 years
June 6, 2022
June 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of primary patency of the target lesion
Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation.
180 days
Secondary Outcomes (3)
Success rate of the device
Intraoperation
Success rate of the technique
Immediately after the intervention
Success rate of the operation
Within 7 days
Other Outcomes (2)
Change of Ankle-Branchial Index(ABI)
180 days
The rate of target lesion revascularization(TLR)
30 days/ 180 days
Study Arms (2)
101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group
EXPERIMENTALPatients in this group use Drug eluting Balloon (Zylox-tonbridge), this is the product to be test in this clinical trail. The drug we coated is paclitaxel.
101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group
ACTIVE COMPARATORPatients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016.
Interventions
Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.
Eligibility Criteria
You may qualify if:
- Age 18-85 years；
- ≥70% diameter stenosis or occlusion in the target below-the-knee lesion；
- Rutherford Category 3-6；
- Subjects are willing to sign informed consent；
You may not qualify if:
- Planned major limb amputation within 30 days after the procedure;
- In-stent stenosis in the target lesion;
- Severely calcified target lesions；
- Creatinine\>2.5mg/dL;
- History of allergies to anesthetics, contrast agents；
- Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；
- Other circumstances judged by researchers that are not suitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
The second hospital of Anhui Medical university
Hefei, Anhui, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
HeNan Province People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, China
The central hospital of Wuhan
Wuhan, Hubei, China
Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school
Nanjing, Jiangsu, China
The First Affiliated Hospital Of Dalian Medical University
Dalian, Liaoning, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
The affiliated Hospital of QingDao University
Qingdao, Shandong, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The affiliated hospital of southwest medical university
Luzhou, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine
Hangzhou, Zhejiang, China
Huamei hospital, University of Chinese academy of sciences
Ningbo, Zhejiang, China
China-Japan Friendship Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Changhai Hospital
Shanghai, China
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junmin Bao
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 13, 2022
Study Start
March 1, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
June 13, 2022
Record last verified: 2022-03