Can a tiny blade on a balloon unblock stubborn lung arteries?

NCT ID NCT01205568

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

73 people

The number who actually took part.

Started

Aug 2003

Finished

Sep 2009

Lead sponsor

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

0 to 18 years

Sex

Anyone

Healthy volunteers

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

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

  • Children's Hospital Boston

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • Children's Hospital, Philadelphia

    Philadelphia, Pennsylvania, 19104-4399, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of California at San Francisco

    San Francisco, California, 94143-0130, United States

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