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Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis

NCT03891693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-17

No results posted yet for this study

Summary

The study evaluates the use of a biomimetic stent (SUPERA®) and a drug eluting balloon (DEB - Passeo 18 Lux) for the treatment of recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas. All participants will undergo angioplasty with stated devices, and be followed up with over 12 months.

Conditions

  • Brachiocephalic Vein Stenosis

Interventions

DEVICE

Passeo-18 Lux and SUPERA® stent

Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Tang Tjun Yip · Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2020-06-30
Completion
2021-01-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891693 on ClinicalTrials.gov