Plain balloon angioplasty vs. Viabhan stent graft as a first treatment for narrowing of the veins after receiving a graft for haemodialysis

Not Applicable

• Conditions: Intervention for venous stenosis in arteriovenous grafts; Urological and Genital Diseases

• Registration Number: ISRCTN47220776
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-30
• Last Update Posted: 27 February 2023
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Target lesion:
1.1.A significant (>50%) venous stenosis on US or DSA, but confirmed severity prior to intervention using DSA,
1.2.Related to the venous anastomosis (within 8cm),
1.3.That has been determined as requiring intervention,
1.4.Normal outflow vein beyond this with minimum caliber 6mm,
1.5.No previous intervention for venous stenosis or ipsilateral venous stenosis
2. Age =18 at the time of informed consent signature.
3. Capable of complying with protocol requirements, including follow-up.
4. An Informed Consent Form signed by the patient.
5. A previously functioning AVG that has had established normal HD parameters (URR/pressures-flows) for a
minimum of 4 weeks.
6. Patient sufficiently fit to withstand maintenance procedures e.g. thrombectomy.
7. No scheduled renal transplant within 60 days.
8. No other outflow tract stenosis, including a normal ipsilateral central venous pathway.

Exclusion Criteria

1. Pregnant female at the time of informed consent signature.
2. AVG implanted less than 4 weeks previously.
3. A plan for conversion to alternative form of renal replacement therapy within 60 days.
4. A history or evidence of severe systemic disease including:
4.1. History of cancer (excludes BCC) with active disease or active anti-tumor (cytotoxic) treatment within the previous
year;
4.2. Suspected or documented hyper-coagulable state, unless willing to take anti-coagulation;
4.3. Recurrent (>1/year) unexplained thrombotic episodes;
5. Known or suspected central vein stenosis / occlusion on the side of AVG.
6. Treatment with any investigational drug within 60 days prior to study entry.
7. Any condition that in the judgment of the investigator would preclude adequate evaluation of the trial end points.
8. Unwilling or unable to have regular surveillance.

Study & Design

• Study Type: Observational
• Study Design: Not specified