Research

Cutting Balloon to Treat Pulmonary Artery Stenosis

Safety and Efficacy of the Cutting Balloon to Treat Resistant Pulmonary Artery Stenosis in Children

Protocol Description

This study will evaluate the safety and efficacy of the cutting balloon catheter for treatment of pulmonary artery stenosis in cases where the patient does not respond to low-pressure dilation. The cutting balloon catheter will be compared to current angioplasty methods including high-pressure balloon techniques. The cutting balloon is similar to a normal balloon used to dilate vessels, but has several thin surgical blades along its length that scratch the inside surface of a vessel and may allow it to stretch open to promote blood flow.

Eligibility Criteria

Eligible candidates include male and female babies and children diagnosed with pulmonary artery stenosis whose blood vessels are not easily stretched open with normal angioplasty balloons inflated to low pressures.
Boys: ages 44 weeks and older
Girls: ages 44 weeks and older

Requirements
Through random selection, candidates will be placed into one of two groups during catheterization. One group will receive the standard balloon inflated to high pressure and the other group will be treated with the cutting balloon. Patients in the standard balloon group who do not respond to the high-pressure balloon may be eligible for cutting balloon treatment.
Visits: Requires hospitalization
Duration: Patients’ progress will be followed for approximately 3 months.

Status: Closed to Enrollment

Sources of Support
Boston Scientific Scimed
Children’s Hospital Boston