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NCT03844724

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

Completed NA Last updated 18 February 2019
What this trial tests

NA trial testing ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in Peripheral Arterial Disease in 204 participants. Completed in 22 October 2018.

Timeline
10 April 2015
Primary endpoint
5 March 2018
22 October 2018

Quick facts

Lead sponsorZhejiang Zylox Medical Device Co., Ltd.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment204
Start date10 April 2015
Primary completion5 March 2018
Estimated completion22 October 2018

Drugs / interventions tested

Conditions studied

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Who can join

Adults 18 to 85, any sex, with Peripheral Arterial Disease or Iliac Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Safety of paclitaxel-coated devices in the femoropopliteal arteries: A systematic review and meta-analysis.
    Zhang C, Yin G. · · 2022 · cited 6× · PMID 36227807 · DOI 10.1371/journal.pone.0275888
  2. A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions.
    Ni L, Ye W, Zhang L, Jin X, et al · · 2022 · cited 1× · PMID 35391838 · DOI 10.3389/fcvm.2022.821672

Verify or expand the search:

Other recruiting trials for Peripheral Arterial Disease

Currently open trials in the same condition.

Other Zhejiang Zylox Medical Device Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

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