Cutting Balloon Study (CB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01205568
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : September 20, 2010
Information provided by:
Boston Children’s Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Artery Stenosis Procedure: Transcatheter Cutting Balloon therapy Procedure: High Pressure Balloon Angioplasty Not Applicable

Boston Children’s Hospital has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:
The proposed study will be a prospective, multi-center, randomized, blinded trial comparing 2 treatments for pulmonary artery stenosis. Specifically, vessels that fail to respond to balloon inflation at 8 ATM will be individually randomized to 1 of 2 treatment pathways. In the first treatment pathway, the vessel is dilated using a CB, followed by additional low pressure balloon dilation (< 8ATM). In the second pathway,the vessel is dilated with high pressure balloon angioplasty, with balloon inflation pressures exceeding 15 ATM. Cross-over therapy will be permitted for failed high pressure treatment starting with enrollment of patient #15. The primary outcome assessment for efficacy will be a comparison of percent change in minimum lumen diameter before and after randomized therapy, as determined by a core laboratory blinded to pathway assignment. The primary outcome assessment for safety will be a comparison of the proportion of vessel dilations resulting in any serious adverse events, as determined by the Data and Safety Monitoring Board. Patient-level safety endpoints will also be tabulated. Patients can have multiple vessels enrolled; analytical techniques will adjust for potential intra-patient correlation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Safety and Efficacy of the Cutting Balloon to Treat Resistant Pulmonary Artery Stenosis

Arm Intervention/treatment
Experimental: Cutting Balloon Procedure: Transcatheter Cutting Balloon therapy
Active Comparator: High Pressure Balloon Angioplasty Procedure: High Pressure Balloon Angioplasty

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01205568

United States, California
University of California at San Francisco
San Francisco, California, United States, 94143-0130
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Children's Hospital, Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4399
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Boston Children’s Hospital
Principal Investigator: Kathy Jenkins, MD, MPH Boston Children’s Hospital

Responsible Party: Kathy Jenkins, MD, MPH, Children's Hospital Boston Identifier: NCT01205568     History of Changes
Other Study ID Numbers: 0502027R
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: September 20, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Constriction, Pathologic
Stenosis, Pulmonary Artery
Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases