Ignite Creation Date:
2024-05-06 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03449875
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2018-01-09
Brief Title:
Global Post-market Registry for the Treovance Stent-graft
Sponsor:
Bolton Medical
Organization:
Bolton Medical
Study Overview
Official Title:
A Post-Market Surveillance Clinical Registry of the TREOVANCE Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
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:
RATIONALE
Brief Summary:
Patients with abdominal aortic aneurysms AAA suitable for endovascular aortic repair EVAR with Treovance were eligible to participate Main inclusion criteria were age 18-85 years infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation infrarenal or distal iliac landing neck size requirements specified in the instructions for use Main exclusion criteria dissectionruptured aneurysm or prior AAA endovascular or surgical repair The primary endpoints were standard EVAR criteria
Detailed Description:
The goal of the registry was to collect clinical data of TREOVANCE device in subjects with infrarenal aortic aneurysms specifically to evaluate if the diseased pathology is treated with an acceptable technical success rate an acceptable complication rate and that the device performs as expected
The following endovascular measuresparameters were assessed for preliminary performance at the follow-up intervals deliverydeployment stent-graft migration stent-graft patency stent-graft integrity endoleak aneurysm sac size changes limb ischemia and vascular access complications
This registry was a prospective multi-center post-market non-randomized study The goal was to gather safety and performance data on the device Subjects diagnosed with infrarenal aortic aneurysms enrolled into the registry were treated with the TREOVANCE Stent-Graft with Navitel Delivery System Pre-procedure baseline data was gathered as well as post-procedure assessments prior to hospital discharge and 1 6 and 12 months post-implantation
The following endovascular measuresparameters were assessed for preliminary performance at the follow-up intervals deliverydeployment stent-graft migration stent-graft patency stent-graft integrity endoleak aneurysm sac size changes limb ischemia and vascular access complications
This registry was a prospective multi-center post-market non-randomized study The goal was to gather safety and performance data on the device Subjects diagnosed with infrarenal aortic aneurysms enrolled into the registry were treated with the TREOVANCE Stent-Graft with Navitel Delivery System Pre-procedure baseline data was gathered as well as post-procedure assessments prior to hospital discharge and 1 6 and 12 months post-implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None