Pulmonary Artery Repair With Covered Stents



Status:Completed
Conditions:Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:7 - 75
Updated:5/10/2018
Start Date:December 2012
End Date:June 30, 2016

Use our guide to learn which trials are right for you!

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.

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.

Inclusion Criteria:

Precatheterization Inclusion Criteria:

1. Patient meets institutional criterion for placement of Melody® TPV

2. Patient size adequate to receive Melody TPV® implantation via venous access using the
Ensemble® Transcatheter Delivery System

3. RV-PA conduit original size > 16 mm diameter

4. 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

Exclusion Criteria:

Precatheterization Exclusion Criteria:

1. Patient size too small for transvenous placement of the Melody® TPV

2. Bloodstream infection, including endocarditis

3. Pregnancy

4. Prisoners and adults lacking the capacity to give consent

Catheterization Exclusion Criteria:

1. Conduit size is not suitable (too small or too large) for a Melody® TPV

2. Risk of coronary compression has been identified

3. Lack of angiographic evidence for RV-PA conduit disruption - Prophylactic use of study
CCPS is prohibited

4. 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
We found this trial at
38
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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Corpus Christi, TX
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
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Miami, FL
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Norfolk, VA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Tampa, Florida 33607
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Tampa, FL
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Ann Arbor, MI
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Dallas, TX
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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Hershey, PA
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1005 Joe DiMaggio Drive
Hollywood, Florida 33021
954-265-JDCH (5324)
Memorial Healthcare System - Joe DiMaggio Children's Hospital Since its inception in 1953, Memorial Healthcare...
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Hollywood, FL
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Houston, TX
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Las Vegas, NV
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Loma Linda, California 92354
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Loma Linda, CA
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Los Angeles, CA
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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Nashville, TN
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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New Orleans, Louisiana 70121
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New Orleans, LA
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New York, NY
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Oak Lawn, Illinois 60453
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Oak Lawn, IL
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Omaha, Nebraska 68114
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Omaha, NE
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Salt Lake City, UT
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San Diego, California 92123
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San Francisco, California 94143
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San Francisco, CA
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Seattle, WA
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...
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Spokane, WA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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