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NCT04393688
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
NA trial testing Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter in Arteriovenous Fistula in 168 participants. Status unknown.
1 July 2020
Quick facts
| Lead sponsor | BrosMed Medical Co., Ltd |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 168 |
| Start date | 25 May 2020 |
| Primary completion | 1 July 2020 |
| Estimated completion | 1 May 2021 |
| Sites | 7 locations across China |
Drugs / interventions tested
- Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter
Conditions studied
- Arteriovenous Fistula — all drugs for Arteriovenous Fistula →
Sponsor
BrosMed Medical Co., Ltd
Who can join
18 and older, any sex, with Arteriovenous Fistula. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04393688
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Arteriovenous Fistula
Currently open trials in the same condition.
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- NCT06527963 — DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis · recruiting
- NCT07314047 — The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation · NA · recruiting
- NCT06553443 — Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis · Phase 3 · recruiting
Other BrosMed Medical Co., Ltd trials
Trials by the same sponsor.
- NCT07187128 — A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or · NA · not yet recruiting
- NCT07010094 — BM Shockwave Devices Clinical Study in Coronary Calcified Lesions · NA · recruiting
- NCT06951724 — Coronary Aspiration Catheter Clinical Trial · NA · recruiting
- NCT06214754 — Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI · NA · completed
- NCT05747287 — Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions · 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 NCT04393688 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BrosMed Medical Co., Ltd
- Last refreshed: 20 May 2020
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/NCT04393688.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing