Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-02-28 @ 7:32 PM
Study NCT ID:
NCT02345005
Status:
UNKNOWN
Last Update Posted:
2023-07-21
First Post:
2015-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iliac Branch Excluder ReGistry (IceBERG)
Sponsor:
Rijnstate Hospital
Organization:
Study Overview
Official Title:
Multi-centre, Observational, Post-market, Real World Registry to Assess Outcomes of Patients Treated With the Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IceBERG
Brief Summary:
This post market registry consists of a retrospective and a prospective part. The first part is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE mark was obtained, to get an initial insight on the feasibility and safety of this procedure. The second part is to prospectively register all data on implanted IBE Gore devices, in order to gain more robust data on the efficacy of the device in maintaining hypogastric artery patency.
Detailed Description:
Rationale: The Gore IBE device is a newly designed iliac branched device, that is used in combination with the widely accepted C3 Excluder endograft for the exclusion of common iliac aneurysms and aorto-iliac aneurysms. The later has a proven safety and efficacy in excluding abdominal aortic aneurysms. The Gore IBE device got CE mark on October 2013. Technical and clinical data at short and long terms are still to be collected to give insight into technical success rates, patency data and long term follow-up.
Objective and design: This investigator-initiated post market registry consists of a retrospective and a prospective part. The first part is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE mark was obtained, to get an initial insight on the feasibility and safety of this procedure. The second part is to prospectively register all data on implanted IBE Gore devices, in order to gain more robust data on the efficacy of the device in maintaining hypogastric artery patency.
Study population: All patients in whom a Gore IBE was or will be implanted. In the retrospective part of the study all implantations in the Netherlands will be gathered, whereas the prospective part will be expanded in Europe.
Main study parameters/endpoints: Aneurysm exclusion and reinterventions will be end-points of this study. As safety and feasibility is the main outcome of the retrospective part, the data will be analyzed at 30-days. Patients in the prospective study will be followed for 5 years, with the primary end-point being hypogastric side branch patency at 1-year. Clinical endpoints include freedom from symptoms of pelvic ischemia (buttock claudication, impotence and bowel ischemia) and freedom from aneurysm rupture.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a registry study, no burden or risk exist for the patient. There is also no direct benefit for the participating patients, but the gathered data will improve insight for patients with the same disease and might improve health care in the future for this group of patients.
Objective and design: This investigator-initiated post market registry consists of a retrospective and a prospective part. The first part is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE mark was obtained, to get an initial insight on the feasibility and safety of this procedure. The second part is to prospectively register all data on implanted IBE Gore devices, in order to gain more robust data on the efficacy of the device in maintaining hypogastric artery patency.
Study population: All patients in whom a Gore IBE was or will be implanted. In the retrospective part of the study all implantations in the Netherlands will be gathered, whereas the prospective part will be expanded in Europe.
Main study parameters/endpoints: Aneurysm exclusion and reinterventions will be end-points of this study. As safety and feasibility is the main outcome of the retrospective part, the data will be analyzed at 30-days. Patients in the prospective study will be followed for 5 years, with the primary end-point being hypogastric side branch patency at 1-year. Clinical endpoints include freedom from symptoms of pelvic ischemia (buttock claudication, impotence and bowel ischemia) and freedom from aneurysm rupture.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a registry study, no burden or risk exist for the patient. There is also no direct benefit for the participating patients, but the gathered data will improve insight for patients with the same disease and might improve health care in the future for this group of patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: