Pulmonary Artery Repair With Covered Stents

Completed · Not applicable

Conditions studied: Pulmonary Stenosis, Pulmonary Regurgitation, Tetralogy of Fallot

In brief

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.

Key facts

Study ID

NCT01824160

Run by

Johns Hopkins University

People needed

50

Starts

2012-12-01

Expected to finish

2016-06-30

Last updated by the study team

2018-05-08

Who can join

Age: 7 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loma Linda University Health — Loma Linda, California, United States
• Children's Hospital of Los Angeles — Los Angeles, California, 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
• University of California, San Francisco — San Francisco, California, United States
• Yale University — New Haven, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Memorial Healthcare System, Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Miami Children's Hospital — Miami, Florida, United States
• St. Joseph's Hospital — Tampa, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Advocate Children's Hospital - Oak Lawn — Oak Lawn, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Congenital Heart Center — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Children's Hospital and Medical Center — Omaha, Nebraska, United States
• Sunrise Children's, Children's Heart Center — Las Vegas, Nevada, United States
• Children's Hospital of New York - Presbyterian — New York, New York, United States
• Cincinnati Children's Hospital and Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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