CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Repair of RV-PA Conduit Disruptiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01824160
NCT01824160N/ACompleted

Pulmonary Artery Repair With Covered Stents

Johns Hopkins University·interventional·Posted Apr 4, 2013·Updated May 8, 2018

In Brief

A clinical study evaluating Repair of RV-PA Conduit Disruption for Pulmonary Stenosis and 2 related conditions. Completed, enrolled 50 participants across 38 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2013
Enrollment StartDec 1, 2012
Primary CompletionSep 30, 2014
Study CompletionJun 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.2 years ago

Interventions

Repair of RV-PA Conduit Disruptiondevice

Repair of RV-PA Conduit Disruption