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Evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System: a prospective, multi-center single-arm clinical trial

Evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System: a prospective, multi-center single-arm clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCC-15006203
Enrollment
Unknown
Registered
2015-04-07
Start date
2015-04-10
Completion date
Unknown
Last updated
2021-06-28

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

Conditions

Abdominal iliac aneurysm or Common iliac artery aneurysms

Interventions

single arm:interventional therapy

Sponsors

The General Hospital of People’s Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. To be aged elder than 18 years old; 2. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial; 3. The patient needs to reconstruct the abdominal iliac aneurysm or common iliac artery aneurysms; 4. Only the anatomical structure of iliac artery meeting the following requirements: (1) The length of landing zone of the external iliac artery greater than 15mm; (2) The diameter of landing zone of the external iliac artery is between 7-12mm; (3) The diameter of the internal iliac artery is between 6-10mm; (4) The length of landing zone of the internal iliac artery greater than 10mm; 5. The patient with at least 1 years survival expectancy.

Exclusion criteria

Exclusion criteria: 1. The patient is younger than 18 years old; 2. Female patients in pregnancy or lactation; 3. The Patient had sufferred myocardial infarction or stroke within 3 months before screening; 4. The Patient suffers form connective tissue disease,infected aneurysms or other active infectionactivity; 5. Patients with ruptured abdominal aortic aneurysm; 6. The Patient has severe coagulation diaorders; 7. Patients with known allergy to the material of the stents and contrast agent; 8. From the view of the Vascular morphology,the patient doesn't suitable for endovascular repair,such as serious in the iliac artery stenosis, expansion, bending, hardening, etc.; 9. Aneurysm cavity with seriously mural thrombus that affect the implantation of Bifurcation stent.

Countries

China

Contacts

Public ContactWei Guo
pla301dml@vip.sina.com+86 010 66887329

Outcome results

None listed

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