NCT03844724

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

February 13, 2019

Last Update Submit

February 15, 2019

Conditions

Peripheral Arterial DiseaseIliac Artery StenosisFemoral Artery StenosisPopliteal Artery StenosisIliac Artery OcclusionFemoral Artery OcclusionPopliteal Artery Occlusion

Keywords

Peripheral Arterial DiseaseDrug-eluting PTA Balloon Dilatation CatheterLate Lumen Loss（6 months）

Outcome Measures

Primary Outcomes (1)

  • Late Lumen Loss at 6 months after operation

    Late Lumen Loss

    6 months

Secondary Outcomes (2)

  • The incidence of major adverse events

    12 months

  • Adverse Event

    Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months

Study Arms (2)

Group A

EXPERIMENTAL

subjects using the drug-eluting PTA balloon dilatation catheter

Device: ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter

Group B

ACTIVE COMPARATOR

subjects using the peripheral balloon dilatation catheter

Device: Peripheral Balloon Dilatation Catheter

Interventions

ZENFlow™ Drug-eluting PTA Balloon Dilatation CatheterDEVICE

Digital subtraction angiography（DSA）

Group A
Peripheral Balloon Dilatation CatheterDEVICE

Digital subtraction angiography（DSA）

Group B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35391838DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Changwei Liu

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 18, 2019

Study Start

April 10, 2015

Primary Completion

March 5, 2018

Study Completion

October 22, 2018

Last Updated

February 18, 2019

Record last verified: 2019-02