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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Atherosclerosis, Peripheral Vascular Disease

Intervention / Treatment
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* Device: Dynalink®-E everolimus-eluting peripheral stent
* Device: Dynalink®-E, everolimus-eluting peripheral stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rutherford Becker Category 2-5 Single de novo or restenotic lesion in the superficial femoral or proximal popliteal artery Disease segment length 30-170 mm >50% diameter stenosis or total occlusion Target reference vessel diameter 4.3-7.3 mm Exclusion Criteria: Target lesion previously treated with stent or surgery Rutherford Becker Category 0, 1, or 6 Immunosuppressive disorder or currently receiving immunosuppressive agents Serum creatinine >2.5 mg/dl

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>This is a prospective, non-randomized, single-arm, multi-center study. A projected 100 patients will receive the stent(s) in this study at approximately 10-15 European sites. The primary objective 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 or proximal popliteal lesions. | Device: Dynalink®-E everolimus-eluting peripheral stent<br>* Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery<br>Device: Dynalink®-E, everolimus-eluting peripheral stent<br>* Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent binary restenosis (>50% stenosis), as measured by duplex ultrasound |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic in-stent binary restenosis rate (>50%) |  | 12 months | 
| Angiographic mean in-stent late loss, in-stent mean minimum lumen diameter (MLD), percent diameter stenosis |  | 12 months | 
| Primary, and secondary patency |  | 1, 6, 12, 18 months, 2, 3, 4, 5 years |