- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01205568
Cutting Balloon Study (CB)
Safety and Efficacy of the Cutting Balloon to Treat Resistant Pulmonary Artery Stenosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94143-0130
- University of California at San Francisco
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-4399
- Children's Hospital, Philadelphia
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
- 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:
3. Patient Exclusion Criteria (Determined Prior to Cardiac Catheterization)
- Prior pulmonary artery angioplasty or surgery on the vessel within the previous 6 weeks
- Pregnancy
Vessel Exclusion Criteria (Determined During Cardiac Catheterization)
- 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
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with Resistant Pulmonary Artery Stenosis
Vessels with resistant PA stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Change in Minimum Lumen Diameter Immediately Post-intervention
Time Frame: Pre-intervention to immediate post-intervention (approximately 10 minutes)
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The primary efficacy outcome is the percent change in minimum lumen diameter from pre-intervention to immediately post-intervention as measured by angiography.
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Pre-intervention to immediate post-intervention (approximately 10 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Minimum Lumen Diameter at 3 Months Post-intervention
Time Frame: 3 months post-intervention
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Late percent change in minimum lumen diameter from pre-intervention to follow-up angiography.
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3 months post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathy Jenkins, MD, MPH, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0502027R
- 75593
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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