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Comparison of SUPERA vs Plain old balloon angioplasty(POBA) on recurrent cephalic arch stenosis in patients with brachiocephalic arteriovenous fistula

Comparison of SUPERA vs Plain old balloon angioplasty(POBA) on recurrent cephalic arch stenosis in patients with brachiocephalic arteriovenous fistula

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009282
Enrollment
100
Registered
2024-03-29
Start date
2022-07-14
Completion date
Unknown
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Selection criteria for subjects undergoing only balloon angioplasty (POBA) 1) Those who consented to the study (Informed consent obtained) 2) Patients aged =21 years and =90 years (Patient aged =21 years and =90 years) 3) Among end-stage renal failure (ESRD) patients on hemodialysis, subjects with brachial artery-northermal cutaneous vein arteriovenous arch stenosis in the brachial artery-lateral cutaneous vein arteriovenous fistula 4) Subjects who can continuously take aspirin or clopidogrel 5]6] 5) Patients with significant recurrent CAS within 6 months of initial POBA, diagnosed either Clinically or with Duplex ultrasound) 6) When residual stenosis is 10% even after multiple balloon angioplasty (POBA) using rigid/cutting balloons *Rigid/cutting balloon (CB) is a catheter for cardiovascular plastic surgery in which three or four metal blades are vertically attached to the surface of the balloon. It cuts the blood vessel wall by making a deliberate incision in the blood vessel wall before full-scale blood vessel dilatation. A device designed to minimize damage.

Exclusion criteria

Exclusion criteria: 1) When lateral cutaneous venous arch stenosis is 7 mm (CAS 7 mm) 2) Patients who previously underwent BMS (bare metal stent) on the lateral cutaneous venous arch (Patients with previous cephalic arch stenting bare metal stents or stent graft [SG]) 3) If there is a concomitant fistula inflow problem [e.g. juxta-anastomotic] that cannot be corrected optimally during the procedure [residual stenosis of 30% or more or vessel lumen diameter of 3 mm or less] during the intervention[>30% residual stenosis or angiographic lumen of 8 mm in diameter 14) Subjects with blood coagulation disorders 15) When life expectancy is less than 6 months (Limited life expectancy [<6 months]) 16) Sepsis or active infection

Design outcomes

Primary

MeasureTime frame
volume flow rate

Secondary

MeasureTime frame
procedural related complication

Countries

Korea, Republic of

Contacts

Public ContactSeoA Sim

Yonsei University Health System, Gangnam Severance Hospital

daaan1222@naver.com+82-2-2019-2473

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026