Skip to content

Randomized controlled multicenter clinical study of the bio-artificial blood vessel safety and effectiveness

Randomized controlled multicenter clinical study of the bio-artificial blood vessel safety and effectiveness

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005152
Enrollment
Unknown
Registered
2014-08-08
Start date
2014-08-11
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Hemodialysis

Interventions

Treatment group:Implanting bio-artificial blood vessels
Control group:Implanting PTFE artificial vascular graft

Sponsors

Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients who need implanting the peripheral arteriovenous graft, age 18-70 years old, and life expectancy greater than two years, can communicate with researchers, can understand the relevant content of the clinical trials, to obey the research plan, can provide the writing signed and dated informed consent.

Exclusion criteria

Exclusion criteria: Patients who are suffering from a serious heart disease or medical history, symptoms of myocardial infarction or stroke 6 months before the clinical trials, or ventricular need continuous treatment of tachycardia, or unstable angina, or a pacemaker; Patients who are suffering from severe peripheral vascular disease or related history, or skin disease around surgery position or skin infectious lesions or other artificial vascular grafts have been implanted, or limb proximal vein or central vein stenosis, thrombosis, or other adjacent disease blocking venous return, or plan to renal transplantation.

Design outcomes

Primary

MeasureTime frame
The cumulative patency rate (360 days after transplantation);

Secondary

MeasureTime frame
Phase I patency rate (180 days or 360 days after transplantation);Phase II patency rate (180 days or 360 days after transplantation);Failure rate;Compression hemostasia time after puncture;

Countries

China

Contacts

Public ContactZhu Chuhong
zhuch99@163.com+86 13896127558

Outcome results

None listed

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