Status:
COMPLETED
Pulmonary Artery Repair With Covered Stents
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Medtronic
Conditions:
Pulmonary Stenosis
Pulmonary Regurgitation
Eligibility:
All Genders
7-75 years
Phase:
NA
Brief Summary
The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the right ventricle ...
Detailed Description
Recent clinical reports from multiple pediatric cardiology programs around the world indicate that the conduit can be repaired using such a stent. In the United States there are no commercially availa...
Eligibility Criteria
Inclusion
- Precatheterization
- Patient meets institutional criterion for placement of Melody® TPV
- Patient size adequate to receive Melody TPV® implantation via venous access using the Ensemble® Transcatheter Delivery System
- RV-PA conduit original size \> 16 mm diameter
- Patient age between 10 and 75 years
- Catheterization
- a. Angiographic evidence for RV-PA conduit disruption including: dissection, aneurysm, pseudo-aneurysm, tears or rupture
- Recognition and treatment of conduit disruption may occur before, during or after implantation of the Melody® TPV
- Conduit disruption related to prior intervention, identified angiographically before conduit dilation is performed during the Melody® implant procedure, can be eligible for CCPS implantation and study inclusion
Exclusion
- Precatheterization
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01824160
Start Date
December 1 2012
End Date
June 30 2016
Last Update
May 8 2018
Active Locations (38)
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1
Loma Linda University Health
Loma Linda, California, United States, 92354
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
3
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90291
4
Rady Children's Hospital and Health Center
San Diego, California, United States, 92123