- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00475566
A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System (STRIDES)
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Klagenfurt, Austria, 9020
- Landeskrankenhaus Klagenfurt
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Wien, Austria, 1090
- Allgemeines Krankenhaus der Stadt Wien- AKH Wien
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Dendermonde, Belgium
- Sint Blasius Hospital
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Gent, Belgium, 3600
- ZOL St. jan
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Gent, Belgium, 9000
- University Hospital
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Bad Krozingen, Germany, 79189
- Herzzentrum Bad Krozingen
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Berlin, Germany, 13347
- The Jewish Hospital Berlin
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Leipzig, Germany, 04289
- Herzzentrum Leipzig
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Tübingen, Germany, 72076
- University Hospital Tübingen
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Mercogliano, Italy, 83013
- Casa di Cura di Montevergine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 1
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.
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Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery
Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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In-stent binary restenosis (>50% stenosis), as measured by duplex ultrasound
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Angiographic in-stent binary restenosis rate (>50%)
Time Frame: 12 months
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12 months
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Angiographic mean in-stent late loss, in-stent mean minimum lumen diameter (MLD), percent diameter stenosis
Time Frame: 12 months
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12 months
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Primary, and secondary patency
Time Frame: 1, 6, 12, 18 months, 2, 3, 4, 5 years
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1, 6, 12, 18 months, 2, 3, 4, 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johannes Lammer, M.D., Allgemeines Krankenhaus der Stadt Wien
Publications and helpful links
General Publications
- Lammer J, Scheinert D, Vermassen F, Koppensteiner R, Hausegger KA, Schroe H, Menon RM, Schwartz LB. Pharmacokinetic analysis after implantation of everolimus-eluting self-expanding stents in the peripheral vasculature. J Vasc Surg. 2012 Feb;55(2):400-5. doi: 10.1016/j.jvs.2011.08.048. Epub 2011 Nov 1.
- Lammer J, Bosiers M, Zeller T, Schillinger M, Boone E, Zaugg MJ, Verta P, Peng L, Gao X, Schwartz LB. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg. 2011 Aug;54(2):394-401. doi: 10.1016/j.jvs.2011.01.047. Epub 2011 Jun 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Medical University of ViennaCompleted
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Cook Research IncorporatedCompleted
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Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary RestenosisNetherlands, Spain, Denmark, Germany, France, Austria, Belgium, India, Italy, New Zealand, Poland, South Africa, Switzerland
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