PARCS: Pulmonary Artery Repair With Covered Stents

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01824160
• Collaborator: Medtronic (Industry)
• Enrollment: 50
• Locations: 38
• Arm: 1
• Duration (Months): 42.9
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Stenosis; Pulmonary Regurgitation; Tetralogy of Fallot	Device: Repair of RV-PA Conduit Disruption	N/A

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

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pulmonary Artery Repair With Covered Stents
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Sep 30, 2014
• Actual Study Completion Date: Jun 30, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Successful Repair of Conduit Disruption [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 = Contained disruption = Partially contained disruption = Uncontained conduit disruption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Health	Loma Linda	California	United States	92354
2	Children's Hospital of Los Angeles	Los Angeles	California	United States	90027
3	University of California, Los Angeles Medical Center	Los Angeles	California	United States	90291
4	Rady Children's Hospital and Health Center	San Diego	California	United States	92123
5	University of California, San Francisco	San Francisco	California	United States	94143
6	Yale University	New Haven	Connecticut	United States	53201
7	Children's National Medical Center	Washington	District of Columbia	United States	20010
8	Memorial Healthcare System, Joe DiMaggio Children's Hospital	Hollywood	Florida	United States	33021
9	Miami Children's Hospital	Miami	Florida	United States	33155
10	St. Joseph's Hospital	Tampa	Florida	United States	33607
11	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30322
12	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
13	Advocate Children's Hospital - Oak Lawn	Oak Lawn	Illinois	United States	60453
14	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
15	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
16	Boston Children's Hospital	Boston	Massachusetts	United States	02115
17	University of Michigan Congenital Heart Center	Ann Arbor	Michigan	United States	48109
18	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
19	St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
20	Children's Hospital and Medical Center	Omaha	Nebraska	United States	68114
21	Sunrise Children's, Children's Heart Center	Las Vegas	Nevada	United States	89109
22	Children's Hospital of New York - Presbyterian	New York	New York	United States	10032
23	Cincinnati Children's Hospital and Medical Center	Cincinnati	Ohio	United States	45229
24	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
25	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
26	Oregon Health & Science University	Portland	Oregon	United States	97239
27	The Pennsylvania State University and The Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
28	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
29	Medical University of South Carolina	Charleston	South Carolina	United States	29425
30	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	United States	37232
31	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411
32	Children's Medical Center Dallas	Dallas	Texas	United States	75235
33	Baylor College of Medicine, Texas Children's Hospital	Houston	Texas	United States	77030
34	Primary Children's Hospital/University of Uta	Salt Lake City	Utah	United States	84113
35	Children's Hospital of the King's Daughters	Norfolk	Virginia	United States	23507
36	Children's Hospital and Regional Medical Center, Seattle	Seattle	Washington	United States	98105
37	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington	United States	99204
38	Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Johns Hopkins University
• Medtronic

Investigators

• Principal Investigator: Richard Ringel, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01824160
• Other Study ID Numbers: G120188
• First Posted: Apr 4, 2013
• Last Update Posted: May 8, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Tetralogy of Fallot; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis

Study Results

Participant Flow

Arm/Group Title	Repair of RV-PA Conduit Disruption
Arm/Group Description	Covered stenting of RV-PA conduit injury Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Repair of RV-PA Conduit Disruption
Arm/Group Description	Covered stenting of RV-PA conduit injury Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption
Overall Participants	50
Age (Count of Participants)
<=18 years	28 56%
Between 18 and 65 years	22 44%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	22 44%
Male	28 56%

Outcome Measures

1. Primary Outcome

Title	Successful Repair of Conduit Disruption
Description	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
Time Frame	Implant of Covered Stent and 6 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Repair of RV-PA Conduit Disruption
Arm/Group Description	Covered stenting of RV-PA conduit injury Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption
Measure Participants	50
Number [participants]	48 96%

Adverse Events

Arm/Group Title	Repair of RV-PA Conduit Disruption
Arm/Group Description	Covered stenting of RV-PA conduit injury Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption
All Cause Mortality
	Repair of RV-PA Conduit Disruption
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Repair of RV-PA Conduit Disruption
	Affected / at Risk (%)	# Events
Total	1/50 (2%)
Cardiac disorders
Stent malposition	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Repair of RV-PA Conduit Disruption
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.