Pulmonary Artery Repair With Covered Stents
PARCS
1 other identifier
interventional
50
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2014
CompletedResults Posted
Study results publicly available
March 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedMay 8, 2018
April 1, 2018
1.8 years
April 1, 2013
February 15, 2016
April 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Successful Repair of Conduit Disruption
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
Implant of Covered Stent and 6 month follow up
Study Arms (1)
Repair of RV-PA Conduit Disruption
OTHERCovered stenting of RV-PA conduit injury
Interventions
Repair of RV-PA Conduit Disruption
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Medtroniccollaborator
Study Sites (38)
Loma Linda University Health
Loma Linda, California, 92354, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California, Los Angeles Medical Center
Los Angeles, California, 90291, United States
Rady Children's Hospital and Health Center
San Diego, California, 92123, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Yale University
New Haven, Connecticut, 53201, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Memorial Healthcare System, Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
St. Joseph's Hospital
Tampa, Florida, 33607, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Advocate Children's Hospital - Oak Lawn
Oak Lawn, Illinois, 60453, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Congenital Heart Center
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Hospital and Medical Center
Omaha, Nebraska, 68114, United States
Sunrise Children's, Children's Heart Center
Las Vegas, Nevada, 89109, United States
Children's Hospital of New York - Presbyterian
New York, New York, 10032, United States
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Baylor College of Medicine, Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Children's Hospital/University of Uta
Salt Lake City, Utah, 84113, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
Children's Hospital and Regional Medical Center, Seattle
Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Delaney JW, Goldstein BH, Bishnoi RN, Bisselou KSM, McEnaney K, Minahan M, Ringel RE; PARCS Investigators. Covered CP Stent for Treatment of Right Ventricular Conduit Injury During Melody Transcatheter Pulmonary Valve Replacement. Circ Cardiovasc Interv. 2018 Oct;11(10):e006598. doi: 10.1161/CIRCINTERVENTIONS.118.006598.
PMID: 30354627DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- RICHARD RINGEL
- Organization
- Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Ringel, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 4, 2013
Study Start
December 1, 2012
Primary Completion
September 30, 2014
Study Completion
June 30, 2016
Last Updated
May 8, 2018
Results First Posted
March 14, 2016
Record last verified: 2018-04