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Vascular Stent

TIGRIS Vascular Stent for Peripheral Arterial Disease (TIGRIS Trial)

N/A
Waitlist Available
Led By John Laird, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).

Eligible Conditions
  • Peripheral Arterial Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days
Secondary study objectives
Number of Participants With Device Success
Number of Participants With Procedural Success

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TIGRIS Vascular StentExperimental Treatment1 Intervention
GORE TIGRIS Vascular Stent
Group II: BARD LifeStentActive Control1 Intervention
BARD LifeStent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TIGRIS Vascular Stent
2012
N/A
~270

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
100 Previous Clinical Trials
32,522 Total Patients Enrolled
15 Trials studying Peripheral Arterial Disease
4,788 Patients Enrolled for Peripheral Arterial Disease
John Laird, MDPrincipal InvestigatorUC Davis
2 Previous Clinical Trials
281 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
196 Patients Enrolled for Peripheral Arterial Disease
~20 spots leftby Dec 2025
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