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NCT03844724
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
NA trial testing ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in Peripheral Arterial Disease in 204 participants. Completed in 22 October 2018.
5 March 2018
Quick facts
| Lead sponsor | Zhejiang Zylox Medical Device Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 204 |
| Start date | 10 April 2015 |
| Primary completion | 5 March 2018 |
| Estimated completion | 22 October 2018 |
Drugs / interventions tested
- ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
- Peripheral Balloon Dilatation Catheter
Conditions studied
- Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
- Iliac Artery Stenosis — all drugs for Iliac Artery Stenosis →
- Femoral Artery Stenosis — all drugs for Femoral Artery Stenosis →
- Popliteal Artery Stenosis — all drugs for Popliteal Artery Stenosis →
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):
-
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 -
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:
- PubMed search for NCT03844724
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Peripheral Arterial Disease
Currently open trials in the same condition.
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- NCT07076082 — Vascular Trial Associated Registry Pilot · Phase 4 · recruiting
- NCT06308562 — Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease · NA · recruiting
Other Zhejiang Zylox Medical Device Co., Ltd. trials
Trials by the same sponsor.
- NCT07049120 — Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions · NA · not yet recruiting
- NCT06605209 — Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. · NA · recruiting
- NCT05841836 — The Safety and Efficacy of the Suture-Mediated Closure System · NA · unknown
- NCT04812444 — Peripheral Venous Stent System in the Treatment of Iliac Vein Stenosis or Occlusion · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03844724 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhejiang Zylox Medical Device Co., Ltd.
- Last refreshed: 18 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03844724.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing