Pulmonary Artery Repair With Covered Stents

Tetralogy of Fallot Clinical Trial

— PARCS  

Official title:

Pulmonary Artery Repair With Covered Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824160
• Other study ID #: G120188
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: June 30, 2016

Study information

• Verified date: April 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2016
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Regurgitation
• Pulmonary Stenosis
• Pulmonary Valve Insufficiency
• Pulmonary Valve Stenosis
• Respiratory Insufficiency
• Tetralogy of Fallot

Intervention

Device:
• Repair of RV-PA Conduit Disruption
Repair of RV-PA Conduit Disruption

Locations

Country	Name	City	State
United States	University of Michigan Congenital Heart Center	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
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	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	The Pennsylvania State University and The Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Healthcare System, Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Baylor College of Medicine, Texas Children's Hospital	Houston	Texas
United States	Sunrise Children's, Children's Heart Center	Las Vegas	Nevada
United States	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	Miami Children's Hospital	Miami	Florida
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Children's Hospital of New York - Presbyterian	New York	New York
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Advocate Children's Hospital - Oak Lawn	Oak Lawn	Illinois
United States	Children's Hospital and Medical Center	Omaha	Nebraska
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Primary Children's Hospital/University of Uta	Salt Lake City	Utah
United States	Rady Children's Hospital and Health Center	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Children's Hospital and Regional Medical Center, Seattle	Seattle	Washington
United States	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington
United States	St. Joseph's Hospital	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; = Contained disruption; = Partially contained disruption; = Uncontained conduit disruption	Implant of Covered Stent and 6 month follow up