Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

NCT03686189 | Unknown DMC

• 1 other identifier: 50CT（CN）
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Aortoiliac Aneurysm; Iliac Aneurysm

Keywords

Iliac Bifurcation Stent Graft System

Outcome Measures

Primary Outcomes (1)

• Patency rate of internal iliac artery

  Patency rate of internal iliac artery \>＝89%

  180days postoperative

Secondary Outcomes (5)

• Technical success rate

  immediate

• Clinical success rate

  30 days and 180days postoperative.

• The incidence of major Adverse Device Effects (ADEs)

  Before discharge, 30 days and 180 days postoperative。

• Device related mortality

  Before discharge, 30 days and 180days postoperative.

• Secondary interventional surgery

  Before discharge, 30 days and 180days postoperative.

Study Arms (1)

Intervention arm

EXPERIMENTAL

Participants will be treated with Iliac Bifurcation Stent Graft System

Device: Iliac Bifurcation Stent Graft System

Interventions

Iliac Bifurcation Stent Graft System DEVICE

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Life expectancy is longer than one year.

You may not qualify if:

• 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.
• Patients with severe mural thrombus in the aneurysm cavity, which may affect the implantation of Branch Stent.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (8)

Beijing Anzhen Hospital, Capital Medical university

Beijing, Beijing Municipality, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

The Frist Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

MeSH Terms

Conditions

Iliac Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wei Guo

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: July 2, 2015
• Primary Completion: November 30, 2018
• Study Completion: January 31, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

CN (8)