Pulmonary StenosisPARCSNCT01824160
Pulmonary Artery Repair With Covered Stents
A study testing Repair of RV-PA Conduit Disruption in people with Pulmonary Stenosis and Pulmonary Regurgitation, run by Johns Hopkins University at 38 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 75 years
- Conditions the study is for
- Pulmonary Stenosis, Pulmonary Regurgitation, Tetralogy of Fallot
- What is being tested?
- Repair of RV-PA Conduit Disruption
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 38 sitesUnited States
- Study dates
- Dec 2012to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Precatheterization Inclusion Criteria:
- Patient meets institutional criterion for placement of Melody® TPV
- Patient size adequate to receive Melody TPV® implantation via venous access using the Ensemble® Transcatheter Delivery System
- RV-PA conduit original size > 16 mm diameter
- Patient age between 10 and 75 years
- Catheterization Inclusion Criteria:
Show all 9Show fewer
- 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
Who cannot join
- Precatheterization Exclusion Criteria:
- Patient size too small for transvenous placement of the Melody® TPV
- Bloodstream infection, including endocarditis
- Pregnancy
- Prisoners and adults lacking the capacity to give consent
- Catheterization Exclusion Criteria:
Show all 10Show fewer
- Conduit size is not suitable (too small or too large) for a Melody® TPV
- Risk of coronary compression has been identified
- Lack of angiographic evidence for RV-PA conduit disruption - Prophylactic use of study CCPS is prohibited
- 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
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
University of Michigan Congenital Heart Center
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Boston Children's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Children's Medical Center Dallas
Dallas, Texas, 75235
Children's Hospital of Michigan
Detroit, Michigan, 48201
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Memorial Healthcare System, Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Baylor College of Medicine, Texas Children's Hospital
Houston, Texas, 77030
Sunrise Children's, Children's Heart Center
Las Vegas, Nevada, 89109
Loma Linda University Health
Loma Linda, California, 92354
Children's Hospital of Los Angeles
Los Angeles, California, 90027
University of California, Los Angeles Medical Center
Los Angeles, California, 90291
Miami Children's Hospital
Miami, Florida, 33155
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 53201
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Children's Hospital of New York - Presbyterian
New York, New York, 10032
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
Advocate Children's Hospital - Oak Lawn
Oak Lawn, Illinois, 60453
Children's Hospital and Medical Center
Omaha, Nebraska, 68114
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Primary Children's Hospital/University of Uta
Salt Lake City, Utah, 84113
Rady Children's Hospital and Health Center
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94143
Children's Hospital and Regional Medical Center, Seattle
Seattle, Washington, 98105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
St. Louis Children's Hospital
St Louis, Missouri, 63110
St. Joseph's Hospital
Tampa, Florida, 33607
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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.
- Being tested
- Repair of RV-PA Conduit Disruption
- Medical subject headings
- Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of RV-PA Conduit DisruptionDevice
Repair of RV-PA Conduit Disruption
| Study group | Role | What they receive |
|---|---|---|
| Repair of RV-PA Conduit Disruption | Other | Covered stenting of RV-PA conduit injury Receives: Device: Repair of RV-PA Conduit Disruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Implant of Covered Stent and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startDec 2012
- Primary completion30 Sep 2014
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary StenosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Richard Ringel, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824160
- Sponsor's protocol ID
- G120188
- Acronym
- PARCS
- Status last verified
- Apr 2018
- First submitted
- 1 Apr 2013
- Last updated
- 8 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 30354627
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery Repair With Covered Stents
- ClinicalTrials.gov ID
- NCT01824160
- Acronym / sponsor ID
- PARCS / G120188
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Dec 2012
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repair of RV-PA Conduit Disruption | Other | Device: Repair of RV-PA Conduit DisruptionCovered stenting of RV-PA conduit injury |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient meets institutional criterion for placement of Melody® TPV
- Patient size adequate to receive Melody TPV® implantation via venous access using the Ensemble® Transcatheter Delivery System
- RV-PA conduit original size > 16 mm diameter
- Patient age between 10 and 75 years
- Angiographic evidence for RV-PA conduit disruption including: dissection, aneurysm, pseudo-aneurysm, tears or rupture
Key exclusion criteria (10 listed)
- Patient size too small for transvenous placement of the Melody® TPV
- Bloodstream infection, including endocarditis
- Pregnancy
- Prisoners and adults lacking the capacity to give consent
- Conduit size is not suitable (too small or too large) for a Melody® TPV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair of RV-PA Conduit DisruptionRepair of RV-PA Conduit Disruption | Device | Repair of RV-PA Conduit Disruption |
Primary outcome
Successful Repair of Conduit Disruption
Time frame: Implant of Covered Stent and 6 month follow up
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30354627Delaney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Ringel, MD principal investigator
Johns Hopkins University
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of RV-PA Conduit Disruption in people with Pulmonary Stenosis and Pulmonary Regurgitation, run by Johns Hopkins University at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Repair of Conduit Disruption (time frame: Implant of Covered Stent and 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01824160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.