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Dexamethasone infusion for Peripheral Arterial Disease (INVADER MRI Trial)
Phase 4
Waitlist Available
Led By David Saloner, PhD
Research Sponsored by University of California, San Francisco
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 from 1 month to 6 months
Awards & highlights
INVADER MRI Trial Summary
This trial will look at how best to restore blood flow to the leg in people with PAD.
Eligible Conditions
- Peripheral Arterial Disease
- Critical Limb Ischemia
- Vascular Disease
INVADER MRI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 1 month to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1 month to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Percent Wall Volume (PWV)
Secondary outcome measures
Change in ktrans
Change in lumen volume (LV) relative to total vessel volume (TVV)
Change in perioperative inflammatory profile (CRP)
+4 moreOther outcome measures
Extended Clinical Adverse Events Monitoring
INVADER MRI Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: DexamethasoneExperimental Treatment1 Intervention
Participants randomized to the Dexamethasone group will receive dexamethasone infusion to the adventitia of the artery following plain-old-balloon-angioplasty (POBA).
Group II: Drug Coated BalloonActive Control1 Intervention
Participants randomized to the Drug Coated Balloon (DCB) group will not receive dexamethasone infusion to the adventitia of the artery following (POBA). They will receive additional angioplasty with a paclitaxel coated balloon.
Group III: Plain Balloon AngioplastyActive Control1 Intervention
Participants randomized to the Plain Balloon Angioplasty will receive balloon angioplasty (POBA) only. They will not receive adventital dexamethasone or paclitaxel.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,865 Total Patients Enrolled
52 Trials studying Peripheral Arterial Disease
108,903 Patients Enrolled for Peripheral Arterial Disease
University of WashingtonOTHER
1,740 Previous Clinical Trials
1,847,905 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
4,803 Patients Enrolled for Peripheral Arterial Disease
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,522 Total Patients Enrolled
10 Trials studying Peripheral Arterial Disease
649 Patients Enrolled for Peripheral Arterial Disease
Frequently Asked Questions
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