Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475566
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2007-05-16
Brief Title:
A Safety and Efficacy Study of the Dynalink-E Everolimus Eluting Peripheral Stent System
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
A Study to Evaluate the Safety and Performance of the Dynalink-E Everolimus Eluting Peripheral Stent System for Treating Atherosclerotic de Novo or Restenotic Native Superficial Femoral and Proximal Popliteal Artery Lesions
Status:
COMPLETED
Status Verified Date:
2011-03
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:
STRIDES
Brief Summary:
The purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal lesions
Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years The decision to discontinue the study is not related to any safety concern The rationale for this proposal is based on the following considerations
The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and no stent fractures and the rate of additional revascularizations has been stable since approximately 14 months after the procedure
Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature show low rates of death reintervention and stent fracture which are consistent with STRIDES and demonstrate the safety of the nitinol stent platform of the DYNALINK-E
Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E - everolimus tissue concentration drops below the quantifiable limit by approximately 17 months after implant and vascular response to the coating is normal with widely patent lumens and struts incorporated into vessel tissue
The safety and performance of the DYNALINK-E has been substantiated by its clinical and pre-clinical data and by the clinical data of similar products Given the demonstrated mechanical integrity of the stent along with the evidence of a healthy long-term vascular response there is a reasonable expectation of continued low event rates
Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years The decision to discontinue the study is not related to any safety concern The rationale for this proposal is based on the following considerations
The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and no stent fractures and the rate of additional revascularizations has been stable since approximately 14 months after the procedure
Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature show low rates of death reintervention and stent fracture which are consistent with STRIDES and demonstrate the safety of the nitinol stent platform of the DYNALINK-E
Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E - everolimus tissue concentration drops below the quantifiable limit by approximately 17 months after implant and vascular response to the coating is normal with widely patent lumens and struts incorporated into vessel tissue
The safety and performance of the DYNALINK-E has been substantiated by its clinical and pre-clinical data and by the clinical data of similar products Given the demonstrated mechanical integrity of the stent along with the evidence of a healthy long-term vascular response there is a reasonable expectation of continued low event rates
Detailed Description:
A prospective Non-Randomized Single-arm Multi-center Clinical Study to Evaluate the Safety and Performance of the Dynalink-E Everolimus Eluting Peripheral Stent System for the Treatment of Atherosclerotic de Novo or Restenotic Native Superficial Femoral and Proximal Popliteal Artery Lesions
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