Cutting Balloon Study (CB)

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01205568
First received: September 17, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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 Intervention
Pulmonary Artery Stenosis
Procedure: Transcatheter Cutting Balloon therapy
Procedure: High Pressure Balloon Angioplasty

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Safety and Efficacy of the Cutting Balloon to Treat Resistant Pulmonary Artery Stenosis

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Enrollment: 65
Arms Assigned Interventions
Experimental: Cutting Balloon Procedure: Transcatheter Cutting Balloon therapy
Active Comparator: High Pressure Balloon Angioplasty Procedure: High Pressure Balloon Angioplasty

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205568

Locations
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
Children's Hospital Boston
Investigators
Principal Investigator: Kathy Jenkins, MD, MPH Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Kathy Jenkins, MD, MPH, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01205568     History of Changes
Other Study ID Numbers: 0502027R, 75593
Study First Received: September 17, 2010
Last Updated: September 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 19, 2014