Trial Outcomes & Findings for Pulmonary Artery Repair With Covered Stents (NCT NCT01824160)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Implant of Covered Stent and 6 month follow up

Results posted on

2018-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Repair of RV-PA Conduit Disruption Covered stenting of RV-PA conduit injury Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pulmonary Artery Repair With Covered Stents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Repair of RV-PA Conduit Disruption n=50 Participants Covered stenting of RV-PA conduit injury Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption
Age, Categorical <=18 years	28 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	22 Participants n=93 Participants
Sex: Female, Male Male	28 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Repair of RV-PA Conduit Disruption n=50 Participants Covered stenting of RV-PA conduit injury Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption
Successful Repair of Conduit Disruption	48 participants

Adverse Events

Repair of RV-PA Conduit Disruption

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Repair of RV-PA Conduit Disruption n=50 participants at risk Covered stenting of RV-PA conduit injury Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption
Cardiac disorders Stent malposition	2.0% 1/50 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

RICHARD RINGEL

Johns Hopkins University

Phone: 410-714-6745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place