Pulmonary Artery Repair With Covered Stents

NCT ID: NCT01824160

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Pulmonary Stenosis; Pulmonary Regurgitation; Tetralogy of Fallot

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Repair of RV-PA Conduit Disruption

Covered stenting of RV-PA conduit injury

Group Type: OTHER

Repair of RV-PA Conduit Disruption

Intervention Type: DEVICE

Repair of RV-PA Conduit Disruption

Interventions

Repair of RV-PA Conduit Disruption

Repair of RV-PA Conduit Disruption

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Ringel, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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

Oregon Health & Science University

Portland, Oregon, United States

The Pennsylvania State University and The Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Children's Medical Center Dallas

Dallas, Texas, 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 of the King's Daughters

Norfolk, Virginia, 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

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30354627 (View on PubMed)

Other Identifiers

G120188

Identifier Type: -

Identifier Source: org_study_id