Safety and Efficacy Study of Iliac Bifurcation Stent Graf... | NCT03686189

Studies
Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

NCT03686189

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 28, 2018Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Aortoiliac Aneurysm
Iliac Aneurysm

Interventions

Iliac Bifurcation Stent Graft System

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2015Actual

Primary Completion Date

Nov 30, 2018Estimated

Completion Date

Jan 31, 2019Estimated

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2018

Last Update Posted Date

Sep 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention arm	Experimental	Participants will be treated with Iliac Bifurcation Stent Graft System	Device: Iliac Bifurcation Stent Graft System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patency rate of internal iliac artery	Patency rate of internal iliac artery >＝89%	180days postoperative

Secondary Outcomes

Measure	Description	Time Frame
Technical success rate	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.	immediate
Clinical success rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
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.
Life expectancy is longer than one year.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital, Capital Medical university		Beijing	Beijing Municipality		China
Chinese PLA General Hospital

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases