← Back to Search

Perflutren for Carotid Artery Disease

Phase 4

Waitlist Available

Led By Kibo Nam, PhD

Research Sponsored by Thomas Jefferson University

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 pre-endarterectomy

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial looks at plaque vulnerability in carotid arteries non-invasively using ultrasound and pressure estimation techniques to measure plaque cap pressure.

Who is the study for?

This trial is for adults over 18 with atherosclerosis who are scheduled for carotid endarterectomy. It's not suitable for pregnant or breastfeeding individuals, those allergic to perflutren, patients with unstable heart conditions, recent cerebral hemorrhage, critical care patients, or those on life support.

What is being tested?

The study tests a technique called SHAPE using contrast-enhanced ultrasound (with Perflutren) to noninvasively estimate pressure gradients across plaque in the carotid artery and compare these estimates to markers of plaque vulnerability.

What are the potential side effects?

Potential side effects may include reactions related to Perflutren such as allergy symptoms if sensitive. Since it's an imaging procedure involving ultrasound contrast agent rather than medication intake, fewer systemic side effects are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-endarterectomy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-endarterectomy

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-endarterectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlation between the pressure gradient and surrogate (imaging and histological) predictors

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

1Treatment groups

Experimental Treatment

Group I: Carotid SHAPE estimationExperimental Treatment1 Intervention

The ultrasound contrast agent is infused (4-10 mL/min). An area within the plaque demonstrating internal flow is selected and a software based calibration algorithm is executed. After selecting the optimal acoustic output power 3D SHAPE volumes of the entire plaque (including the carotid artery) are acquired. Infusion is stopped and after microbubble clearance a second set of 3D SHAPE volumes (without contrast) are obtained.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perflutren

2012

N/A

~40

Do I qualify?Apply below to find out