Clinical Trial: Systemic Rapamycin (Sirolimus) to Prevent In-Stent Restenosis Following Pulmonary Artery Stent Placement
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Systemic Rapamycin (Sirolimus) to Prevent In-Stent Restenosis Following Pulmonary Artery Stent Placement
Brief Summary:
This is a research study to assess whether an oral medication can benefit some patients being treated for peripheral pulmonary stenosis (PPS), which is narrowing of the blood vessels that send blood to the lungs (pulmonary arteries).
In the cardiac catheterization laboratory, the investigators treat PPS by dilating the narrowed segments of pulmonary arteries using balloon catheters. Sometimes the investigators also place stents which are mesh tubes that help keep the narrowed vessel open. Some stents suffer from in-growth of tissue into the stents which causes recurrent obstructions inside the stent (i.e. making the opening inside the mesh tube narrow again), so called in-stent stenosis (ISS).
The purpose of this study is to use a medication that is approved for use in children (for a different purpose) to decrease the amount of cell ingrowth inside the stents (i.e. decrease the problematic in-stent stenosis). The medication is called rapamycin, also known as sirolimus (trade name Rapamune). It has antiproliferative properties which means that it slows down cell division which the investigators believe cause the recurrent narrowing inside stents.
Rapamycin is a medicine that can be taken by mouth as a liquid or pill or via a feeding tube. There will still be a need for interventions in the catheterization laboratory but the investigators hope that by taking this medicine some children would need fewer catheterizations in the future. Our early experiences with a few patients who have been treated with rapamycin due to in-stent stenosis in the pulmonary arteries suggest that it may be helpful.
In this study, patients and families who are interested in possibly trying this new approach will be randomized to sirolimus or no siro
Detailed Summary:
This is a research study to assess whether an oral medication can benefit some patients being treated for peripheral pulmonary stenosis (PPS). PPS, which can be associated with several different congenital heart diseases, is narrowing of the blood vessels that send blood to the lungs (pulmonary arteries) to pick up oxygen before returning the blood to the heart and the rest of the body. The right ventricle (RV) is the pumping chamber that pumps blood into the pulmonary arteries and the lungs.
PPS can result in high RV pressure, reduced blood flow to one lung, or uneven blood flow within either lung. If left untreated these abnormalities place affected children at risk for abnormal RV function and failure of this pumping chamber which may be seen as decreased ability to do exercise, heart rhythm problems, fainting, or even death.
In the cardiac catheterization laboratory, the investigators treat PPS by dilating the narrowed segments of pulmonary arteries using balloon catheters. Sometimes the investigators also place stents which are mesh tubes that help keep the narrowed vessel open. Some stents suffer from in-growth of tissue into the stents which causes recurrent obstructions inside the stent (i.e. making the opening inside the mesh tube narrow again), so called in-stent stenosis (ISS). This effectively causes recurrent PPS and recurrence of the associated risks listed above.
The purpose of this study is to use a medication that is approved for use in children (for a different purpose) to decrease the amount of cell ingrowth inside the stents (i.e. decrease the problematic in-stent stenosis). The medication is called rapamycin, also known as sirolimus (trade name Rapamune), and has been used safely for many years in children and adults after organ transplantation to preve
Sponsor: Boston Children’s Hospital
Current Primary Outcome: Percent change in in-stent stenosis [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- RV pressure [ Time Frame: 6 months ]
- Adverse drug event [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Boston Children’s Hospital
Dates:
Date Received: February 11, 2015
Date Started: February 2015
Date Completion: February 2019
Last Updated: April 11, 2017
Last Verified: April 2017
