N/A N=50 Treatment

Pulmonary Artery Repair With Covered Stents

Pulmonary Stenosis · Pulmonary Regurgitation · Tetralogy of Fallot

Bottom Line

View on ClinicalTrials.gov: NCT01824160 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Mar 2016

Primary outcome: Primary: Successful Repair of Conduit Disruption — 48 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Repair of RV-PA Conduit Disruption (Device)
Age: Pediatric, Adult, Older Adult · 7+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Successful Repair of Conduit Disruption	48	—

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.

Eligibility Criteria

Inclusion Criteria

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:

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:

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:

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01824160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.