Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT05082532
Status:
UNKNOWN
Last Update Posted:
2021-10-19
First Post:
2021-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
NOT_YET_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:
None
Brief Summary:
Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.
Detailed Description:
Stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (PTA) or long lesion length. However, in-stent restenosis (ISR) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. Besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal Nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. Investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropopliteal complex occlusive lesions.
Study Oversight
Has Oversight DMC:
False
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?: