CompletedNCT03844724Updated Feb 18, 2019

Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion

An interventional study of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter and Peripheral Balloon Dilatation Catheter in Peripheral Arterial Disease, Iliac Artery Stenosis and Femoral Artery Stenosis, sponsored by Zhejiang Zylox Medical Device Co., Ltd.. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-02-18.

Sponsored by Zhejiang Zylox Medical Device Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 3 years 10 months after the study started (first participant enrolled Apr 2015, registered Feb 2019).

Phase: Not applicable
Study type: Interventional
Enrollment: 204
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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

Read the 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.

Conditions studied

Peripheral Arterial Disease
Iliac Artery Stenosis
Femoral Artery Stenosis
Popliteal Artery Stenosis
Iliac Artery Occlusion
Femoral Artery Occlusion
Popliteal Artery Occlusion

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Keywords

Peripheral Arterial Disease
Drug-eluting PTA Balloon Dilatation Catheter
Late Lumen Loss（6 months）

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 204 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Zhejiang Zylox Medical Device Co., Ltd. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

Pregnant woman or who's pregnancy test is positive
Lactation period woman or woman/man with fertility plan

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 204 participants (actual)

Study arms

Experimental
Group A
subjects using the drug-eluting PTA balloon dilatation catheter
Device: ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
Active comparator
Group B
subjects using the peripheral balloon dilatation catheter
Device: Peripheral Balloon Dilatation Catheter

Interventions

DeviceZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
Digital subtraction angiography（DSA）
DevicePeripheral Balloon Dilatation Catheter
Digital subtraction angiography（DSA）

What researchers measure

Primary outcomes

Late Lumen Loss at 6 months after operation
Late Lumen Loss
Time frame: 6 months

Secondary outcomes

The incidence of major adverse events
Related to death of clinical trials
Time frame: 12 months
Adverse Event
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

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 35391838 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03844724
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Responsible party: Sponsor
First posted: Feb 18, 2019
Start date: Apr 10, 2015
Primary completion: Mar 5, 2018
Completion: Oct 22, 2018
Last update: Feb 18, 2019

Study contacts

Changwei Liu

principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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