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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 below

IMPERIAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 60 months for reporting.

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 more
Other 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.
~57 spots leftby Mar 2025