Who is sponsoring NCT01205568?

NCT01205568 is sponsored by Boston Children's Hospital.

What drugs are being tested in NCT01205568?

Interventions in NCT01205568: Transcatheter Cutting Balloon therapy, High Pressure Balloon Angioplasty.

What condition does NCT01205568 study?

NCT01205568 studies Pulmonary Artery Stenosis.

Is NCT01205568 still recruiting?

NCT01205568 is currently completed. Last updated 25 May 2018.

Are results published for NCT01205568?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-05-25 · How we verify

NCT01205568: CB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cutting Balloon Study

Completed NA Results posted Last updated 25 May 2018

What this trial tests

NA trial testing Transcatheter Cutting Balloon therapy in Pulmonary Artery Stenosis in 73 participants. Completed in 9 September 2009.

Timeline

1 August 2003

Primary endpoint
17 March 2009

9 September 2009

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	73
Start date	1 August 2003
Primary completion	17 March 2009
Estimated completion	9 September 2009
Sites	6 locations across United States

Drugs / interventions tested

Transcatheter Cutting Balloon therapy
High Pressure Balloon Angioplasty

Conditions studied

Pulmonary Artery Stenosis — all drugs for Pulmonary Artery Stenosis →

Sponsor

Boston Children's Hospital

Who can join

Eligibility, any sex, with Pulmonary Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acute Change in Minimum Lumen Diameter Immediately Post-intervention Primary · Pre-intervention to immediate post-intervention (approximately 10 minutes)

The primary efficacy outcome is the percent change in minimum lumen diameter from pre-intervention to immediately post-intervention as measured by angiography.

Cutting Balloon

Group	Value	95% CI
Patients With Resistant Pulmonary Artery Stenosis	85.1	± 77.1

High Pressure Balloon Dilation

Group	Value	95% CI
Patients With Resistant Pulmonary Artery Stenosis	52.4	± 66

Percent Change in Minimum Lumen Diameter at 3 Months Post-intervention Secondary · 3 months post-intervention

Late percent change in minimum lumen diameter from pre-intervention to follow-up angiography.

Cutting Balloon

Group	Value	95% CI
Patients With Resistant Pulmonary Artery Stenosis	75.6	± 97.8

High Pressure Balloon Dilation

Group	Value	95% CI
Patients With Resistant Pulmonary Artery Stenosis	42.2	± 66.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Patients were monitored for adverse events from the time of enrollment to follow-up assessment 2-4 months after the intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Resistant Pulmonary Artery Stenosis

Serious: 0/73 (0%)

Deaths: —

Other adverse events (8 terms — click to expand)

Reaction	System	Patients With Resistant Pu…
Pulmonary Edema	Cardiac disorders	—
Balloon Rupture	Cardiac disorders	—
Device malfunction	Cardiac disorders	—
Balloon caught on stent	Cardiac disorders	—
Fracture of catheter shaft	Cardiac disorders	—
Intravascular tear	Cardiac disorders	—
Hemoptysis, hypotension	Cardiac disorders	—
Heart Block	Cardiac disorders	—

Data from ClinicalTrials.gov NCT01205568 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Pulmonary Artery Stenosis

Currently open trials in the same condition.

NCT05086016 — Growth Trial: Study of the Renata Minima Stent · NA · active not recruiting
NCT03287024 — BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants · NA · active not recruiting

Other Boston Children's Hospital trials

Trials by the same sponsor.

NCT06804382 — Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP · NA · not yet recruiting
NCT05113394 — Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy · Phase 2 · withdrawn
NCT06434220 — Effect of Predictive Model on ED Physician Assessments of Patient Disposition · NA · not yet recruiting
NCT07476430 — Readiness Outcomes Affecting Return to Sport 3.0 · NA · not yet recruiting
NCT06706336 — Radon Asthma Intervention Trial · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01205568 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Children's Hospital
Last refreshed: 25 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01205568.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing