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Intravascular Imaging
Angiography with IVUS for Dialysis Access Malfunction
Phase 4
Waitlist Available
Led By William Shutze, MD
Research Sponsored by Baylor Research Institute
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 every 3 months - up to 2 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
The reason the investigators are doing this study is to compare the results of angiography versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are blocked.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months - up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months - up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in characteristics of lesion within the vessel
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: Angiography with IVUSExperimental Treatment1 Intervention
Evaluation with angiography and intravascular ultrasound.
Group II: AngiographyActive Control1 Intervention
Evaluation by angiography only.
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Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,225 Total Patients Enrolled
William Shutze, MDPrincipal InvestigatorBaylor Health Care System
1 Previous Clinical Trials
200 Total Patients Enrolled
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