Pulmonary Artery Repair With Covered Stents (PARCS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Richard E. Ringel, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01824160
First received: April 1, 2013
Last updated: February 15, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Pulmonary Stenosis
Pulmonary Regurgitation
Tetralogy of Fallot
Device: Repair of RV-PA Conduit Disruption

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Artery Repair With Covered Stents

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Successful Repair of Conduit Disruption [ Time Frame: Implant of Covered Stent and 6 month follow up ] [ Designated as safety issue: No ]

    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


Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: June 2016
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824160

  Show 38 Study Locations
Sponsors and Collaborators
Richard E. Ringel
Medtronic
Investigators
Principal Investigator: Richard Ringel, MD Johns Hopkins University
  More Information

Responsible Party: Richard E. Ringel, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01824160     History of Changes
Other Study ID Numbers: G120188 
Study First Received: April 1, 2013
Results First Received: February 15, 2016
Last Updated: February 15, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pulmonary Valve Stenosis
Tetralogy of Fallot
Pulmonary Valve Insufficiency
Respiratory Insufficiency
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Valve Diseases
Ventricular Outflow Obstruction
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 21, 2016