In-stent Stenosis Clinical Trial
Official title:
Systemic Rapamycin (Sirolimus) to Prevent In-Stent Restenosis Following Pulmonary Artery Stent Placement
| Verified date | April 2018 |
| Source | Boston Children’s Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 sirolimus. The investigators will compare the
developement of ISS over time between these groups, in a hope to learn whether oral sirolimus
reduces ISS development.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months and older |
| Eligibility |
Inclusion Criteria: - In-stent stenosis: At least one stent from at least one prior catheterization affected by in-stent stenosis (=25% stenosis and a diameter narrower or equal to the distal vessel). - At least one of the following: - RV hypertension: At least one half systemic RVp or = 70 mm Hg by echocardiogram or per baseline hemodynamics on most recent catheterization - Pulmonary blood flow maldistribution: = 25% of flow to either lung or regional decrease in individual lobar segments. - Pulmonary hypertension: Mean PA pressure = 20 mmHg in unobstructed segments by most recent catheterization. - Informed consent of patient and/or parent/guardian - Agreement to participate in protocol, including follow-up testing Exclusion Criteria: - Age = 6 months - Pulmonary artery surgery or transcatheter PA dilations in the past 6 weeks. - Malignancy (past or present) - Active infection - Pregnancy (current or planned within the next 1 year) - Organ dysfunction as evidenced by laboratory abnormalities - Renal: BUN > 40 mg/dL, or Cr > normal limit for age (by powerchart). Exceptions can be made at the discretion of the study physician if BUN or Cr elevation is known to be due to diuretic management with plan to reduce dosing, or other reversible mechanism. - Hepatic: AST or ALT > 120 unit/L, or total bilirubin > 3 mg/dL - Immune: WBC < 2,000, or ANC or ALC < 1,000 - Hematologic: Hgb< 7 g/dL, or Hct< 21%, or platelet count < 80,000. Exceptions can be made at the discretion of the study physician if plans include transfusion of blood products in the catheterization laboratory and a known reversible etiology for the anemia. - Lipids: Total cholesterol > 250 mg/dL, HDL < 30 g/dL |
| Country | Name | City | State |
|---|---|---|---|
| United States | Boston Children's Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Children’s Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent change in in-stent stenosis | 6 months | ||
| Secondary | RV pressure | 6 months | ||
| Secondary | Adverse drug event | 6 months |