Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~

Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~ - Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009556

Enrollment

374

Registered

2012-12-15

Start date

2012-12-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hemodialysis vascular access stenosis

Interventions

PTA(Percutaneous transluminal angioplasty) Peripheral Cutting Balloon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patient receiving hemodialysis for end stage renal disease with stenotic hemodialysis fistura or graft located on the upper extremities 2.Patient has stenotic vascular access necessary for PTA within 6 months after either surgical procedure or PTA for the stenotic lesion (PTA is indicated when vascular access stenosis is >= 50% and at least one of the clinical or physiological abnormalities are recognized) 3.PTA thought by the investigator to be the best treatment choice 4.Patient capable of providing written informed consent 5.Reference vessel for the targeted stenotic lesion with the diameter of >=3mm and <=6.5mm 6.Hemodialysis vascular access constructed more than 30 days prior to enrollment

Exclusion criteria

Exclusion criteria: 1.Patient incapable of providing written informed consent 2.Life expectancy <6 months 3.Severe allergy to contrast medium 4.Active vascular access infection 5.Pregnancy 6.A Stent placed at the target lesion 7.An angulation of target lesion >=45 degrees 8.The reference vessel diameter <2mm 9.The target stenosis >20mm in length 10.Total occlusion 11.Severe calcification of target lesion 12.Junctional lesion needed for double guide-wire technique 13.Target lesion with branches unable to protect 14.Severely tortuous vessel proximal to the lesion 15.Multiple stenotic lesion needed for multiple sheath insertion

Design outcomes

Primary

Measure	Time frame
6-month primary patency rate	—

Secondary

Measure	Time frame
Duration of primary patency of the hemodialysis vascular access (Treatment area primary patency and access circuit primary patency) Complication Anatomical success Clinical success Procedural success Ultrasonographic finding before and after PTA(Percutaneous transluminal angioplasty) Subjective assessment of pain during balloon-cathether inflation Ultrasonographic finding at 3 months and 6 months after the intervention Angiography at 6 months	—

Measure

Time frame

Duration of primary patency of the hemodialysis vascular access (Treatment area primary patency and access circuit primary patency) Complication Anatomical success Clinical success Procedural success Ultrasonographic finding before and after PTA(Percutaneous transluminal angioplasty) Subjective assessment of pain during balloon-cathether inflation Ultrasonographic finding at 3 months and 6 months after the intervention Angiography at 6 months

—

Countries

Japan

Contacts

Public ContactMasaaki Murakami

Shizuoka General Hospital Department of Nephrology

mmurakami77207@gmail.com054-247-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026