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Drug-eluting Stent
ELUVIA (Stent Implantation) for Peripheral Artery Disease (IMPERIAL Trial)
N/A
Waitlist Available
Led By Stefan Müller-Hülsbeck, Prof
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects age 18 and older.
Subject (or Legal Guardian if applicable) is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits. NOTE: For subjects less than 20 years of age enrolled at a Japanese center, the subject's legal representative, as well as the subject, must provide written informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 60 months
Awards & highlights
IMPERIAL Trial Summary
This study is evaluating whether a drug-eluting stent can be used to treat long lesions in the arteries of the leg.
Eligible Conditions
- Peripheral Artery Disease
IMPERIAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIMPERIAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Reaching Primary Patency
Percentage of Participants With Major Adverse Events (MAEs)
Secondary outcome measures
6-Minute Walk Test - Distance Walked
6-Minute Walk Test - Speed
Count of Participants Meeting Primary Sustained Clinical Improvement
+3 moreOther outcome measures
Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate
Freedom From Major Adverse Events
Percentage of Participants With Target Limb Major Amputation
IMPERIAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ELUVIA Stent ImplantationExperimental Treatment1 Intervention
Percutaneous stent placement in the SFA/PPA
Group II: Zilver PTX Stent ImplantationActive Control1 Intervention
Percutaneous stent placement in the SFA/PPA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ELUVIA (Stent Implantation)
2015
N/A
~530
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
715 Previous Clinical Trials
933,966 Total Patients Enrolled
Stefan Müller-Hülsbeck, ProfPrincipal InvestigatorEv. Luth. Diakonissenanstalt Flensburg
William Gray, MDPrincipal InvestigatorMain Line Health
8 Previous Clinical Trials
2,566 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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