Pulmonary Artery Repair With Covered Stents (PARCS)
|Pulmonary Stenosis Pulmonary Regurgitation Tetralogy of Fallot||Device: Repair of RV-PA Conduit Disruption|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pulmonary Artery Repair With Covered Stents|
- Successful Repair of Conduit Disruption [ Time Frame: Implant of Covered Stent and 6 month follow up ]
Successfully cover a tear or disruption in a RV-PA conduit wall and prevent the development of rupture or bleeding into the mediastinum during additional enlargement of the conduit. Provide persistent conduit wall integrity.
A severity of illness scale categorizes the degree of clinical illness at baseline to be compared to the remaining level of illness after placement of the Covered CP Stent (CCPS). We assess the number of participants with minimal level of illness (level 0 to 1) after CCPS placement.
0 = No injury or conduit wall disruption
- = Contained disruption
- = Partially contained disruption
- = Uncontained conduit disruption
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||June 2016|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Repair of RV-PA Conduit Disruption
Covered stenting of RV-PA conduit injury
Device: Repair of RV-PA Conduit Disruption
Repair of RV-PA Conduit Disruption
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 available, FDA approved, covered stents of the size required. The Covered Cheatham Platinum Stent (CCPS) manufactured by the NuMED Corporation of Hopkinton, New York has been used in Europe since 2003 and more recently in Canada. The CCPS device is not yet approved by the Food & Drug Administration (FDA). However, it has been used at many hospitals in the U.S. to repair Right Ventricle to pulmonary artery conduits under Emergency and Compassionate Use circumstances. The NuMED Covered Cheatham-Platinum Stent (CCPS) is currently being studied for use in other areas of the body. The investigators are now studying its use in RV-PA conduits. The use of the Covered Cheatham Platinum Stent in this research study is investigational.
Only patients found to have a conduit tear during a Melody Valve implant procedure will be eligible for inclusion into the trial. Implant technique is left to the catheterization physician. Clinical data obtained during the catheterization, before and after the CCPS implant will be studied in order to understand factors leading up to the tear and to evaluate how successful the CCPS is in repairing such defects. Melody valve implant patients are routinely seen for clinical and echocardiographic reevaluation 6 months after implant. Patients who have received a CCPS during their Melody valve procedure will likewise be seen. Results from their clinical evaluation will be reviewed to make sure that the presence of a CCPS does not diminish the effectiveness of the Melody valve. Finally, the catheterization angiograms and 6 month follow up echocardiograms will be reviewed by an independent expert to confirm the clinical readings.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824160
Show 38 Study Locations
|Principal Investigator:||Richard Ringel, MD||Johns Hopkins University|