Back to resultsDrug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Primary Purpose
Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
Peripheral Balloon Dilatation Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Drug-eluting PTA Balloon Dilatation Catheter, Late Lumen Loss（6 months）
Eligibility Criteria
Inclusion Criteria:
- Aged from 18 to 85 years old, male or female
- Subject's target lesions were stenosis and/or occlusion
- Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent
Exclusion Criteria:
- Pregnant woman or who's pregnancy test is positive
- Lactation period woman or woman/man with fertility plan
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
subjects using the drug-eluting PTA balloon dilatation catheter
subjects using the peripheral balloon dilatation catheter
Outcomes
Primary Outcome Measures
Late Lumen Loss at 6 months after operation
Late Lumen Loss
Secondary Outcome Measures
The incidence of major adverse events
Related to death of clinical trials
Adverse Event
Adverse medical events, whether or not related to the medical device
Full Information
NCT ID
NCT03844724
First Posted
February 13, 2019
Last Updated
February 15, 2019
Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03844724
Brief Title
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Official Title
Safety and Efficacy of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Iliac, Femoral and Popliteal Artery Stenosis or Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2015 (Actual)
Primary Completion Date
March 5, 2018 (Actual)
Study Completion Date
October 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
Detailed Description
The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis, Popliteal Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Occlusion, Popliteal Artery Occlusion
Keywords
Peripheral Arterial Disease, Drug-eluting PTA Balloon Dilatation Catheter, Late Lumen Loss（6 months）
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
subjects using the drug-eluting PTA balloon dilatation catheter
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
subjects using the peripheral balloon dilatation catheter
Intervention Type
Device
Intervention Name(s)
ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
Intervention Description
Digital subtraction angiography（DSA）
Intervention Type
Device
Intervention Name(s)
Peripheral Balloon Dilatation Catheter
Intervention Description
Digital subtraction angiography（DSA）
Primary Outcome Measure Information:
Title
Late Lumen Loss at 6 months after operation
Description
Late Lumen Loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The incidence of major adverse events
Description
Related to death of clinical trials
Time Frame
12 months
Title
Adverse Event
Description
Adverse medical events, whether or not related to the medical device
Time Frame
Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged from 18 to 85 years old, male or female
Subject's target lesions were stenosis and/or occlusion
Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent
Exclusion Criteria:
Pregnant woman or who's pregnancy test is positive
Lactation period woman or woman/man with fertility plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changwei Liu
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
35391838
Citation
Ni L, Ye W, Zhang L, Jin X, Shu C, Jiang JS, Yang M, Wu DM, Li M, Yu GF, Yang J, Huang JH, Wang XB, Li XQ, Jiang WL, Wu ZQ, Liu CW. A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions. Front Cardiovasc Med. 2022 Mar 15;9:821672. doi: 10.3389/fcvm.2022.821672. eCollection 2022.
Results Reference
derived
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Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
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