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Study Protocol for Paradigm Shift in Vascular Access Creation

Study Protocol for Paradigm Shift in Vascular Access Creation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093537
Enrollment
Unknown
Registered
2024-12-06
Start date
2024-12-09
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

arteriovenous fistula

Interventions

M-RADAR group:In the M-RADAR technique, a longitudinal skin incision was made near the vessels in the forearm. Subcutaneous adipose tissue was carefully separated using curved hemostatic forceps to ex
CT group:In the CT procedure, a longitudinal forearm incision was made. After adequate vein mobilization and devascularization, an end-to-side anastomosis was performed between the vein and artery usi

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years, with no gender restrictions; (2) Diagnosis of end-stage renal disease and a preference for hemodialysis; (3) Initial arteriovenous fistula creation on the surgical side of the upper extremity, meeting vascular criteria outlined in Figure 3, including a patent return vein, a cephalic vein diameter >= 2 mm, a postoperative cannulation length of >=10 cm, radial artery diameter >= 1.5 mm, and a distance between the cephalic vein and radial artery not exceeding 2 cm on ultrasound, with no significant stenosis or calcification in the artery; (4) Expected survival duration >12 months; (5) Informed consent and willingness to participate in clinical follow-up.

Exclusion criteria

Exclusion criteria: (1) Those currently enrolled in another clinical trial involving drugs or medical devices; (2)Pregnant or breastfeeding women; (3) Patients with an ejection fraction (EF) <30% as assessed by echocardiography; (4) Patients with severe pathological changes in other organs, including the cardiovascular and cerebrovascular systems, within the past month. (5) Patients with a life expectancy of less than one year; (6) Patients with central venous lesions on the operative side, including a history of central venous catheterization, breast cancer surgery, cardiac pacemaker implantation, or other central venous ; (7) Patients diagnosed with severe infections; (8) Patients with arterial stenosis on the operative side.

Design outcomes

Primary

MeasureTime frame
Access primary patency;Incidence of stenosis at the anastomotic site;

Secondary

MeasureTime frame
Maturity rate;Access assisted primary patency;Access cumulative patency;Complications associated with AVF: infection, thrombosis, stenosis, steal syndrome;Time to first cannulation;Mortality rate;Hospitalization rate due to AVF-related complications;

Countries

China

Contacts

Public ContactShi Yaxue

Longhua Hospital Shanghai University of Traditional Chinese Medicine

dshiyaxue2024@163.com+86 139 1833 1840

Outcome results

None listed

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