Pulmonary Artery Repair With Covered Stents

Brief Title

Pulmonary Artery Repair With Covered Stents

Official Title

Pulmonary Artery Repair With Covered Stents

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.
    


Study Type

Interventional


Primary Outcome

Successful Repair of Conduit Disruption


Condition

Pulmonary Stenosis

Intervention

Repair of RV-PA Conduit Disruption

Study Arms / Comparison Groups

 Repair of RV-PA Conduit Disruption
Description:  Covered stenting of RV-PA conduit injury

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

December 2012

Completion Date

June 30, 2016

Primary Completion Date

September 30, 2014

Eligibility 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
      

Gender

All

Ages

7 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Richard Ringel, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01824160

Organization ID

G120188


Responsible Party

Sponsor

Study Sponsor

Johns Hopkins University

Collaborators

 Medtronic

Study Sponsor

Richard Ringel, MD, Principal Investigator, Johns Hopkins University


Verification Date

April 2018