A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty

A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty - A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to DCB angioplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059132

Enrollment

100

Registered

2025-09-24

Start date

2025-09-24

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

End-stage renal disease, hemodialysis vascular access stenosis

Interventions

intervention: pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty control: pre-dilatation with a conventional balloon prior to drug-coated balloon angioplasty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age more than 20 years 2. AV fistula created at least 30 days prior to enrollment 3. At least 8 out of the most recent 12 dialysis sessions were completed without complications 4. Presence of more than 50% stenosis from the anastomosis site to the axillary vein or subclavian vein entry 5. In cases with two stenotic lesions, both must be treatable with a single drug-coated balloon 6. For tandem lesions, the distance between lesions must be within 3 cm 7. Reference vessel diameter at the target lesion must be between 4 mm and 8 mm 8. Written informed consent obtained based on sufficient understanding and voluntary agreement to participate in the study 9. Ability to attend follow up visits after treatment 10. Both de novo and restenotic lesions are eligible for inclusion

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant, breastfeeding, or planning to become pregnant, and men who wish to father children 2. Scheduled to undergo kidney transplantation within 6 months 3. Planned transition to peritoneal dialysis within 6 months 4. Underwent vascular intervention for access within the past 30 days 5. Presence of severe AV access infection or systemic infection contraindicating PTA 6. Scheduled for surgical revision of the AV access within 6 months 7. Presence of secondary lesions requiring additional treatment within 30 days 8. Severe ischemia of the limb contraindicating PTA 9. Presence of advanced malignancy or systemic infection with an expected life expectancy of less than 6 months 10. Moderate to severe vessel tortuosity at the target site that precludes the use of a cutting balloon 11. Presence of visible thrombus at the target lesion that contraindicates the use of a drug coated balloon 12. Presence of a stent at the stenotic site

Design outcomes

Primary

Measure	Time frame
Target legion primary patency rate at 6 months	—

Countries

Japan

Contacts

Public ContactMASAAKI MURAKAMI

Shizuoka General Hospital Department of Nephrology

mmurakami77207@gmail.com0542476111

Outcome results

None listed

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