To study the consequences of doing dilatation of vein using "saline jet plus balloon catheter" versus "saline jet plus malleable metal dilator" in small calibre veins (2mm or less) and their impact on surgically created connection between artery and vein that is required for performing dialysis.

Hydrostatic dilatation plus balloon angioplasty versus hydrostatic dilatation plus malleable vascular dilator for 2mm or less caliber veins used during creation of arteriovenous fistula for hemodialysis. A randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/05/008543

Enrollment

100

Registered

2017-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Chronic Kidney Disease type V patients visiting surgery clinic for creation of Arterio venous fistula for the purpose of haemodialysis

Interventions

Intervention1: Hydrostatic dilatation plus balloon angioplasty: Hydrostatic dilatation with balloon angioplasty: About 5 cm of length of cephalic vein is identified and isolation from its adhesions to

Eligibility

Inclusion criteria

Inclusion criteria: 1. CKD 4-5 patients visiting surgery clinic for creation of AVF for haemodialysis 2. 18 to 65 years of age both male and female 3. Radial artery with normal duplex ultrasound (DUS) parameters 4. Luminal diameter of vein 5. Sufficient backflow could not be confirmed after venotomy 6. Patient can follow instructions 7. Patients are ready for regular follow up 8. unable to provide informed written consent

Exclusion criteria

Exclusion criteria: 1. History of previous surgery on vessels in the ipsilateral upper limb 2. Ipsilateral central venous stenosis or occlusions of vein that is not amenable to correction 3. Vein diameter > 2.0-mm or when 2mm coronary dilator can be easily passed through cephalic vein. 4. Segmental or complete occlusion of vein detected on preoperative duplex ultrasonography. 5. Steal syndrome requiring surgical ligation. 6. Vessels that are too frail to be cannulated. 7. Vein is injured due to cannulation or surgical procedure (e.g., perforation of vein and bleeding). 8. Brachial artery or radial artery extensive disease (calcified or atherosclerosed artery) detected on preoperative DUS. 9. absence of bruit after arterio-venous fistula surgery 10. Non-compliance with medical care or follow up 11. Patient suffering from psychiatry problems 12. Unable to give consent or patient refusal 13. Medical risk factors • Hypertension - SBP >180, DBP >90; • Hypotension - SBP • NYHC IV heart failure

Design outcomes

Primary

Measure	Time frame
1. Six-month primary patency rate 2. Maturation of AV fistulaTimepoint: day 2 week 4 week 8 week 24	—

Secondary

Measure	Time frame
1. Re-intervention rates 2. Cost of treatmentTimepoint: week 24	—

Countries

India

Contacts

Public ContactManjunath Maruti Pol

All India Institute of Medical Science New Delhi

manjunath.pol@gmail.com9990187137

Outcome results

None listed

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