Cutting Balloon Study

NCT01205568 | Completed Results DMC

• 2 other identifiers: 0502027R75593
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 6

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.

Conditions

Pulmonary Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Acute Change in Minimum Lumen Diameter Immediately Post-intervention

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

  Pre-intervention to immediate post-intervention (approximately 10 minutes)

Secondary Outcomes (1)

• Percent Change in Minimum Lumen Diameter at 3 Months Post-intervention

  3 months post-intervention

Study Arms (1)

Patients with Resistant Pulmonary Artery Stenosis

EXPERIMENTAL

Vessels with resistant PA stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation

Device: Transcatheter Cutting Balloon therapy; Procedure: High Pressure Balloon Angioplasty

Interventions

Transcatheter Cutting Balloon therapy DEVICE

Patients with Resistant Pulmonary Artery Stenosis

High Pressure Balloon Angioplasty PROCEDURE

Patients with Resistant Pulmonary Artery Stenosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Prior pulmonary artery angioplasty or surgery on the vessel within the previous 6 weeks
• Pregnancy
• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (6)

University of California at San Francisco

San Francisco, California, 94143-0130, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital, Philadelphia

Philadelphia, Pennsylvania, 19104-4399, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stenosis, Pulmonary Artery

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kathy Jenkins MD MPH
• Organization: Boston Childrens Hospital

kathy.jenkins@childrens.harvard.edu

6173557275

Study Officials

• Kathy Jenkins, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 20, 2010
• Study Start: August 1, 2003
• Primary Completion: March 17, 2009
• Study Completion: September 9, 2009
• Last Updated: May 25, 2018
• Results First Posted: May 25, 2018

Record last verified: 2018-04

Locations

US (6)