Can a tiny blade on a balloon unblock stubborn lung arteries?
NCT ID NCT01205568
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether a cutting balloon, a catheter with tiny blades that score the vessel wall before expanding, can safely widen branch pulmonary arteries that resist standard low-pressure balloon dilation. Researchers will compare the cutting balloon to high-pressure balloon angioplasty in 73 people with pulmonary artery stenosis. The main measure is how much the artery diameter increases right after the procedure, with a follow-up check at 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcatheter Cutting Balloon therapy
- What this could lead to
- If it works, this could offer a more effective way to open narrowed pulmonary arteries in children and adults, improving blood flow to the lungs.
- What could go wrong
- The trial is early and small, and the cutting balloon may not outperform standard angioplasty. Risks include vessel injury or complications during the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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73 people
The number who actually took part.
- Started
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Aug 2003
- Finished
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Sep 2009
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patient Inclusion Criteria (Determined Prior to Cardiac Catheterization) a. At least 1 branch pulmonary artery stenosis referred for planned catheterization for PA dilation b. At least one of the following: i.greater than one half systemic right ventricular pressure ii. regional decrease in pulmonary blood flow by lung scan iii. elevated pulmonary artery pressures (\> 20 mmHg MPAP) iv. cyanosis at least in part due to PA stenosis c. Informed consent of patient and/or parent/guardian; assent of mature minors d. Agreement to participate in protocol, including follow-up testing Vessel Inclusion Criteria (Determined During Cardiac Catheterization) 1. Native pulmonary artery or branch which fails balloon dilation up to 8 ATM; as defined by failure to eliminate a waist 2. 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 3. 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: 3\. Patient Exclusion Criteria (Determined Prior to Cardiac Catheterization) 1. Prior pulmonary artery angioplasty or surgery on the vessel within the previous 6 weeks 2. Pregnancy Vessel Exclusion Criteria (Determined During Cardiac Catheterization) 1. 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. 2. Prior stent placement associated with the obstruction i. balloon inflation for the purpose of expanding the diameter of the stent along its length with no residual waist proximal or distal to the stent edges ii. balloon inflation resulting in waist formation within the edges of a stent iii. dilation of a vessel through the cells of a stent c. Unifocalized nor non-unifocalized systemic to pulmonary artery collaterals. d. A vessel requiring therapy at a site not amenable to delivery or safe positioning of a Cutting Balloon device due to unfavorable anatomy as determined by the physician and based on as assessment of vessel angles, size, length, and proximity to other vessels.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital Boston
Boston, Massachusetts, 02115, United States
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Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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Children's Hospital, Philadelphia
Philadelphia, Pennsylvania, 19104-4399, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
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University of California at San Francisco
San Francisco, California, 94143-0130, United States
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