NCT01205568

Cutting Balloon Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and efficacy of transcatheter Cutting Balloon therapy for branch pulmonary artery stenosis resistant to low pressure dilation.

Detailed description

The proposed study will be a prospective, multi-center, randomized, blinded trial comparing 2 treatments for pulmonary artery stenosis. Specifically, vessels that fail to respond to balloon inflation at 8 ATM will be individually randomized to 1 of 2 treatment pathways. In the first treatment pathway, the vessel is dilated using a CB, followed by additional low pressure balloon dilation (\< 8ATM). In the second pathway,the vessel is dilated with high pressure balloon angioplasty, with balloon inflation pressures exceeding 15 ATM. Cross-over therapy will be permitted for failed high pressure treatment starting with enrollment of patient #15. The primary outcome assessment for efficacy will be a comparison of percent change in minimum lumen diameter before and after randomized therapy, as determined by a core laboratory blinded to pathway assignment. The primary outcome assessment for safety will be a comparison of the proportion of vessel dilations resulting in any serious adverse events, as determined by the Data and Safety Monitoring Board. Patient-level safety endpoints will also be tabulated. Patients can have multiple vessels enrolled; analytical techniques will adjust for potential intra-patient correlation.

Conditions

• Pulmonary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Cutting Balloon therapy
PROCEDURE	High Pressure Balloon Angioplasty

Timeline

• Start date: 2003-08-01
• Primary completion: 2009-03-17
• Completion: 2009-09-09
• First posted: 2010-09-20
• Last updated: 2018-05-25
• Results posted: 2018-05-25

Locations

6 sites across 1 country: United States