UnknownNot Applicable

Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

China64 participantsStarted 2015-07-02

Plain-language summary

A prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Older than 18 years of age.
✓. The subject or its legal representative sign the informed consent.
✓. Patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery.
✓. The anatomical structure of the iliac artery meets the following requirements:
✓. The length of the anchoring zone of the external iliac artery is ≥15mm.
✓. The diameter of the anchoring zone of the external iliac artery is between 7mm and 12mm.
✓. The diameter of the external iliac artery is between 6mm-10mm.
✓. The length of the anchoring zone of the internal iliac artery is ≥10mm.

✕. The patient is under 18 years old.
✕. Pregnant or lactating woman.
✕. The patient had a myocardial infarction or stroke within 3 months.
✕. The patient had connective tissue disease, infectious aneurysm, and other active infections.
✕. The patient has abdominal aortic aneurysm rupture.
✕. The patient has a severe coagulation disorder.
✕. Allergic to the material of stent or contrast media.
✕. Patient's vascular morphology is not suitable for endovascular repairs, such as serious stricture, dilate, bend, sclerosis, etc. of the iliac artery.

Patency rate of internal iliac artery

Timeframe: 180days postoperative

NCT IDNCT03686189

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-30