CompletedNot Applicable

Cutting Balloon Study

United States73 participantsStarted 2003-08-01

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. Native pulmonary artery or branch which fails balloon dilation up to 8 ATM; as defined by failure to eliminate a waist
✓. Native pulmonary artery or branch with a balloon waist diameter less than 7.5 mm (i.e.,0.5 mm less than the largest available CB) with dilation at 8 ATM
✓. All eligible vessels that are dilated during the catheterization must be enrolled as study vessels; "off-study" use of Cutting Balloons or high pressure dilations in eligible vessels is not allowed.

Exclusion criteria

✕. Prior pulmonary artery angioplasty or surgery on the vessel within the previous 6 weeks
✕. Pregnancy
✕. Vessel with an aneurysm from a prior dilation or surgery, defined as a local enlargement of the vessel greater than 100% of the lumen diameter both proximally and distally to the aneurysm. The maximum aneurysm diameter and vessel lumen diameter proximal and distal to the aneurysm will be recorded. The location of the aneurysm relative to the angioplasty site will be determined and reported as proximal, distal, or in the region of waist formation.
✕. Prior stent placement associated with the obstruction

What they're measuring

Acute Change in Minimum Lumen Diameter Immediately Post-intervention

Timeframe: Pre-intervention to immediate post-intervention (approximately 10 minutes)

Trial details

NCT IDNCT01205568

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03-17

Results submitted2017-04-18

View on ClinicalTrials.gov More Pulmonary Artery Stenosis trials