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A Multi-centre Observational Clinical Trial Based on IBE Registry for a FDA-approved Iliac Branch Endoprosthesis in Chinese Patients with Aortoiliac Aneurysms

A Multi-centre Observational Clinical Trial Based on IBE Registry for a FDA-approved Iliac Branch Endoprosthesis in Chinese Patients with Aortoiliac Aneurysm

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079990
Enrollment
Unknown
Registered
2024-01-17
Start date
2024-01-20
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Abdominal Aortic Aneurysm with Common Iliac Artery Aneurysm

Interventions

IBE Group:The combined use of the GORE? EXCLUDER? Iliac Branch Endoprosthesis with the abdominal aortic covered stent system for the treatment of Chinese patients with abdominal aortic aneurysm combin

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Population aged 18 and above; (2) Chinese nationality; (3) Patients sign a written informed consent form; (4) Elective surgery, suitable for endovascular repair of abdominal aortic aneurysm combined with common iliac artery aneurysm; As assessed by the primary physician, in the real world, the GORE® EXCLUDER® Iliac Branch Endoprosthesis combined with an abdominal aortic covered stent system is used for the treatment of Chinese patients with abdominal aortic aneurysm combined with common iliac artery aneurysm.

Exclusion criteria

Exclusion criteria: (1) Patients with an expected lifespan of less than one year; (2) Patients suffering from psychiatric illness or other diseases that may affect the study; (3) Patients known to be allergic to any component of the device (ePTFE, FEP, nickel-titanium alloy); (4) Patients with systemic infections may have an increased risk of intravascular graft infection; (5) Patients with coagulation disorders or uncontrollable bleeding disorders; (6) Patients with ruptured, leaking, or mycotic aneurysms; (7) Patients with pseudoaneurysms, isolated common iliac aneurysms, or isolated abdominal aortic dissections; (8) Patients with autoimmune diseases, Marfan syndrome; (9) Patients who have had variant asthma or myocardial infarction in the past three months; (10) Pregnant patients (applicable only to women of childbearing potential); (11) Inability to complete follow-up.

Design outcomes

Primary

MeasureTime frame
The safety and feasibility of the GORE? EXCLUDER? Abdominal Aortic Covered Stent System within 30 days post-operation, including the technical success rate and the incidence of complications within 30 days post-operation.;The one-year postoperative patency rate of the iliac treatment side, aneurysm isolation, and the rate of type II endoleak unrelated to the stent.;

Secondary

MeasureTime frame
The patency of the EIA (External Iliac Artery) and IIA (Internal Iliac Artery);gluteal claudication;Erectile dysfunction;Intestinal ischemia;Stent-related Type I, Type II, and Type III endoleaks;Aneurysm rupture;Mortality rate;

Countries

China

Contacts

Public ContactLi Yongjun

Beijing Hospital

liyongjun4679@bjhmoh.cn+86 135 0109 9799

Outcome results

None listed

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