Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180505
Status:
COMPLETED
Last Update Posted:
2010-02-24
First Post:
2005-09-13
Brief Title:
ASSESS Study Evaluation of ABSOLUTE Stent System for Occluded Arteries
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Non-Randomized Prospective Multi-center Evaluation of the ABSOLUTE 035 Peripheral Self-Expanding Stent System for Occluded or Stenotic Superficial Femoral or Proximal Popliteal Arteries
Status:
COMPLETED
Status Verified Date:
2010-02
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:
None
Brief Summary:
The purpose of this study is to investigate the performance of the ABSOLUTE 035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries
Detailed Description:
The treatment of stenosis in superficial femoral arteries andor proximal popliteal arteries with stenting is associated with high restenosis rates especially with the first generation stents stainless steel Currently self-expandable nitinol stents are commercialized which lead to higher primary patency rates as compared to the first generation stents even in longer lesions However until now most data available are retrospective and uni-center The ASSESS study is a prospective multi-center study investigating the performance restenosis rate patency rates of the ABSOLUTE 035 peripheral self-expandable stent in longer lesions lesion length from 400 mm to 20000 mm
Moreover literature shows stent fracture in nitinol stents with a possible clinical relationship For this reason the ASSESS study will analyze the stent fractures of the ABSOLUTE stent and a possible relationship between stent fracture and restenosis
Moreover literature shows stent fracture in nitinol stents with a possible clinical relationship For this reason the ASSESS study will analyze the stent fractures of the ABSOLUTE stent and a possible relationship between stent fracture and restenosis
Study Oversight
Has Oversight DMC:
None
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?:
None