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Using a Patient's Own Leg Vein to Create or Repair Dialysis Access: A Clinical Study

Application and Clinical Research of Autologous Great Saphenous Vein Graft in Arteriovenous Fistula Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112130
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Chronic Kidney Disease (CKD)

Interventions

AGSV-GAVF group :None
AVF group:None
AVG group:None

Sponsors

Yingtan 184 Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Arterial Conditions: The diameter of the radial artery/brachial artery is = 50%), or calcification (vascular wall calcification score >= 2 points), which fails to meet the blood flow requirements after anastomosis. 2.Venous Conditions: The diameter of the cephalic vein/basilic vein is 1 second); or upper extremity venous agenesis exists due to previous surgery or trauma. 3.History of Previous Failed Autologous AVF Surgery: An attempt to establish an upper extremity autologous arteriovenous fistula (AVF) (e.g., radial artery-cephalic vein fistula) was made within 1 year, but the surgery failed due to poor vascular conditions (e.g., immediate absence of blood flow after anastomosis, access occlusion within 1 month postoperatively). 4.Diameter: The diameter of the selected segment (thigh or calf segment) of the blood vessel shall be >= 3.0 mm (the measurement point is the midpoint of the vessel, excluding dilatation at the valve site) to ensure that the blood flow after transplantation meets the standard (target: >=200 ml/min). 5.Patency: The blood vessel is patent throughout its entire length, with no thrombosis, stenosis (stenosis rate < 30%), inflammation (e.g., thrombophlebitis), or malformation (e.g., venous aneurysmal dilatation). 6.Anatomical Integrity: The great saphenous vein has a clear course, with no severe adhesions (e.g., anatomical structural disorder caused by previous lower extremity surgery). It can be completely harvested via minimally invasive or open approaches, and lower extremity venous return remains unaffected after harvesting (e.g., the lower extremity deep veins are patent and can compensate for the function of superficial veins).

Exclusion criteria

Exclusion criteria: 1.Diameter = 200 ml/min). 2.Presence of moderate to severe lesions: Total or segmental occlusion, thrombosis (regardless of acute or chronic phase), stenosis (stenosis rate >= 30%, which impairs blood flow conduction), or complicated with severe inflammation (e.g., acute thrombophlebitis, which is prone to cause post-transplant infection or vascular wall fibrosis after harvesting). 3.Anatomical Abnormalities: Disordered course (e.g., severe adhesions between the vein, muscles, and nerves caused by previous lower extremity fractures or tumor surgeries, making complete dissection and harvesting impossible), congenital malformations (e.g., absence of venous valves, multi-branch malformations, which lead to hemodynamic disorders after transplantation), or lower extremity deep vein occlusion/dysfunction (e.g., post-thrombotic syndrome, primary deep venous valve insufficiency). Such conditions result in inability to compensate for superficial venous return after harvesting, easily causing complications like lower extremity swelling and ulcers. 4.Congestive heart failure (New York Heart Association [NYHA] Class IV), or left ventricular ejection fraction (LVEF) < 30%: Changes in intraoperative anesthesia and hemodynamics may induce acute heart failure. 5.Severe chronic obstructive pulmonary disease (COPD) in acute exacerbation, or arterial partial pressure of oxygen (PaO2) < 60 mmHg (in non-oxygen-supplemented state): Unable to tolerate general anesthesia or epidural anesthesia. 6.Acute myocardial infarction or stroke occurring within a recent period (3 months), or uncontrolled malignant arrhythmia (e.g., sustained ventricular tachycardia): The surgical risk is significantly increased. 7.Active Infection or Systemic Disease; 8.Severe Coagulopathy / Severe Coagulation Dysfunction.

Design outcomes

Primary

MeasureTime frame
6-Month Postoperative Primary Patency Rate;

Secondary

MeasureTime frame
1-Year Postoperative Secondary Patency Rate;

Countries

China

Contacts

Public ContactXie Xiaojie

Yingtan 184 Hospital

94048071@qq.com+86 701 6636900

Outcome results

None listed

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