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Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

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ClinicalTrials.gov Identifier: NCT03686189
Recruitment Status : Unknown
Verified September 2018 by Lifetech Scientific (Shenzhen) Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Lifetech Scientific (Shenzhen) Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Aortoiliac Aneurysm Iliac Aneurysm Device: Iliac Bifurcation Stent Graft System Not Applicable

Detailed Description:
A prospective, multi-center, Single-Arm clinical trial to evaluate the safety and efficacy of endovascular treatment of the aortoiliac aneurysm or the iliac aneurysm by using Iliac Bifurcation Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. According to the requirements of the study, 64 patients preoperatively diagnosed with the aortoiliac aneurysm or the iliac aneurysm will be recruited and be treated by Iliac Bifurcation Stent Graft System under the guidance of aortic aortography. The safety of operations, stability of releasing stent and the accuracy of positioning will be evaluated intraoperatively. The safety and efficacy of aortic endovascular treatment of Iliac Bifurcation Stent Graft System will be observed by postoperative follow up scheduled 30 days and 180 days after the operation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Iliac Bifurcation Stent Graft System, A Prospective, Multi-centre, Single-Arm Clinical Trial
Actual Study Start Date : July 2, 2015
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention arm
Participants will be treated with Iliac Bifurcation Stent Graft System
 Device: Iliac Bifurcation Stent Graft System
Device placement after preoperative preparation. For patients with the aortoiliac aneurysm, the placement of short-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft, or the placement of long-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft are recommended.


Outcome Measures
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Primary Outcome Measures :
  1. Patency rate of internal iliac artery [ Time Frame: 180days postoperative ]
    Patency rate of internal iliac artery >＝89%


Secondary Outcome Measures :
  1. Technical success rate [ Time Frame: immediate ]
    After implantation of the stent and observed under common iliac artery angiography, the stent was in the right position and adhered well to the vessel wall, with no leakage.

  2. Clinical success rate [ Time Frame: 30 days and 180days postoperative. ]
    The diameter of the common iliac artery aneurysm was not expanded or expanded less than 3mm.

  3. The incidence of major Adverse Device Effects (ADEs) [ Time Frame: Before discharge, 30 days and 180 days postoperative。 ]
    Major Adverse Device Effects including death, myocardial infarction, arterial thrombosis, renal function failure, respiratory failure, paraplegia, stroke, gluteus claudication, colon, spinal cord ischemia necrosis, perineum, iliac artery blockages, external iliac vein blockage, expand common iliac artery aneurysms (increased diameter 3 mm), common iliac artery aneurysms rupture, internal leakage (type I and type III), stent fracture, stent displacement.

  4. Device related mortality [ Time Frame: Before discharge, 30 days and 180days postoperative. ]
    Deaths related to the device.

  5. Secondary interventional surgery [ Time Frame: Before discharge, 30 days and 180days postoperative. ]
    The rate of secondary interventional surgery for complications related to the device


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Older than 18 years of age.
  2. The subject or its legal representative sign the informed consent.
  3. Patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery.

  4. The anatomical structure of the iliac artery meets the following requirements:

    1. The length of the anchoring zone of the external iliac artery is ≥15mm.
    2. The diameter of the anchoring zone of the external iliac artery is between 7mm and 12mm.
    3. The diameter of the external iliac artery is between 6mm-10mm.
    4. The length of the anchoring zone of the internal iliac artery is ≥10mm.
  5. Life expectancy is longer than one year.

Exclusion Criteria:

  1. The patient is under 18 years old.
  2. Pregnant or lactating woman.
  3. The patient had a myocardial infarction or stroke within 3 months.
  4. The patient had connective tissue disease, infectious aneurysm, and other active infections.
  5. The patient has abdominal aortic aneurysm rupture.
  6. The patient has a severe coagulation disorder.
  7. Allergic to the material of stent or contrast media.
  8. Patient's vascular morphology is not suitable for endovascular repairs, such as serious stricture, dilate, bend, sclerosis, etc. of the iliac artery.
  9. Patients with severe mural thrombus in the aneurysm cavity, which may affect the implantation of Branch Stent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686189


Locations
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China, Beijing
Beijing Anzhen Hospital, Capital Medical university
Beijing, Beijing, China
Chinese PLA General Hospital
Beijing, Beijing, China
Peking Union Medical College Hospital
Beijing, Beijing, China
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
China, Shanghai
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China
China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China
China, Zhejiang
The Frist Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
China
Jiangsu Province Hospital
Nankín, China
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
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Principal Investigator: Wei Guo Chinese PLA General Hospital
More Information
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Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03686189    
Other Study ID Numbers: 50CT（CN）
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lifetech Scientific (Shenzhen) Co., Ltd.:
Iliac Bifurcation Stent Graft System
Additional relevant MeSH terms:
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Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases