Pulmonary Artery Repair With Covered Stents (PARCS)

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.

Study Overview

• Status: Completed
• Conditions: Tetralogy of Fallot; Pulmonary Regurgitation; Pulmonary Stenosis
• Intervention / Treatment: Device: Repair of RV-PA Conduit Disruption

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
    • Los Angeles, California, United States, 90291
      • University Of California, Los Angeles Medical Center
    • San Diego, California, United States, 92123
      • Rady Children's Hospital and Health Center
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Connecticut
    • New Haven, Connecticut, United States, 53201
      • Yale University
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System, Joe DiMaggio Children's Hospital
    • Miami, Florida, United States, 33155
      • Miami Children's Hospital
    • Tampa, Florida, United States, 33607
      • St. Joseph's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Children's Hospital - Oak Lawn
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Congenital Heart Center
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Children's Hospital and Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Children's, Children's Heart Center
  • New York
    • New York, New York, United States, 10032
      • Children's Hospital of New York - Presbyterian
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital and Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • The Pennsylvania State University and the Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Texas
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Children's Hospital
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine, Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital/University of Uta
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of The King's Daughters
  • Washington
    • Seattle, Washington, United States, 98105
      • Children's Hospital and Regional Medical Center, Seattle
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center and Children's Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Repair of RV-PA Conduit Disruption; Covered stenting of RV-PA conduit injury	Device: Repair of RV-PA Conduit Disruption; Repair of RV-PA Conduit Disruption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Medtronic
• Investigators: Principal Investigator: Richard Ringel, MD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): September 30, 2014
• Study Completion (ACTUAL): June 30, 2016

Study Registration Dates

• First Submitted: April 1, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (ESTIMATE): April 4, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Tetralogy of Fallot; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Other Study ID Numbers: G120188