Pulmonary Artery Repair With Covered Stents
- Conditions
- Pulmonary StenosisPulmonary RegurgitationTetralogy of Fallot
- Interventions
- Device: Repair of RV-PA Conduit Disruption
- Registration Number
- NCT01824160
- Lead Sponsor
- Johns Hopkins University
- 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 of the heart to the pulmonary arteries. Patients undergoing replacement of their pulmonary valve by transcatheter technique Melody Valve) are at risk of developing such tears in the process of preparing the conduit to accept the new valve. In order to implant such a valve, the connection between the right ventricle and the pulmonary arteries often needs to be enlarged. High pressure balloons may be needed and these balloons can sometimes cause tears in or even rupture of the connecting conduit. Such tears can allow blood to flow into the chest and rarely this can lead to a life-threatening emergency. Experience suggests that such tears can be closed by implanting into the conduit a metallic stent with an outer covering, rebuilding the wall and allowing continuation of the valve implant.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Precatheterization Inclusion Criteria:
- 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 Inclusion Criteria:
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
Precatheterization Exclusion Criteria:
- Patient size too small for transvenous placement of the Melody® TPV
- Bloodstream infection, including endocarditis
- Pregnancy
- Prisoners and adults lacking the capacity to give consent
Catheterization Exclusion Criteria:
- Conduit size is not suitable (too small or too large) for a Melody® TPV
- Risk of coronary compression has been identified
- Lack of angiographic evidence for RV-PA conduit disruption - Prophylactic use of study CCPS is prohibited
- Vessel injury occurring in either the right or left branch pulmonary arteries -If injury to branch pulmonary arteries occurs during the catheterization and covered stent usage is indicated, Emergency Use guidelines must be employed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Repair of RV-PA Conduit Disruption Repair of RV-PA Conduit Disruption Covered stenting of RV-PA conduit injury
- Primary Outcome Measures
Name Time Method Successful Repair of Conduit Disruption 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
1. = Contained disruption
2. = Partially contained disruption
3. = Uncontained conduit disruption
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Loma Linda University Health
🇺🇸Loma Linda, California, United States
Memorial Healthcare System, Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Advocate Children's Hospital - Oak Lawn
🇺🇸Oak Lawn, Illinois, United States
Children's Hospital of New York - Presbyterian
🇺🇸New York, New York, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Congenital Heart Center
🇺🇸Ann Arbor, Michigan, United States
Sunrise Children's, Children's Heart Center
🇺🇸Las Vegas, Nevada, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine, Texas Children's Hospital
🇺🇸Houston, Texas, United States
Primary Children's Hospital/University of Uta
🇺🇸Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center, Seattle
🇺🇸Seattle, Washington, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Children's Hospital and Medical Center
🇺🇸Omaha, Nebraska, United States
Cincinnati Children's Hospital and Medical Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of California, Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Rady Children's Hospital and Health Center
🇺🇸San Diego, California, United States
St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States