NCT00475566

A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Atherosclerosis
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Dynalink®-E everolimus-eluting peripheral stent	Stenting of atherosclerotic de novo or restenotic lesions (\> 50% stenosis) in the native superficial femoral or proximal popliteal artery
DEVICE	Dynalink®-E, everolimus-eluting peripheral stent	Stenting of atherosclerotic de novo or restenotic lesions (\> 50% stenosis) in the native superficial femoral or proximal popliteal artery

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-07-01
• Completion: 2010-02-01
• First posted: 2007-05-21
• Last updated: 2011-03-10

Locations

10 sites across 4 countries: Austria, Belgium, Germany, Italy