Clinical trial NCT05086016: Growth Trial: Study of the Renata Minima Stent
Official title: GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coarctation of the Aorta
Pulmonary Artery Stenosis
Lead sponsor: Renata Medical
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.


Eligibility criteria: Inclusion criteria include:

* The subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent
* Requiring treatment\* of:

  * native, acquired, or recurrent aortic coarctation, or
  * native, acquired, or recurrent pulmonary artery stenosis \*As defined by the patient's medical team
* Patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system
* Adjacent vessel to stenosis measuring \> or equal to 4 mm

Exclusion criteria include:

* Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
* History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation
* Aortic or pulmonary artery aneurysm in the location targeted for treatment
* Body weight \< 1.5 kg
* Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent
* Target vessels larger or smaller than the Minima System balloon size ranges
* Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
* Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.
* Currently participating in an investigational drug study or another device study
* Major or progressive non-cardiac disease resulting in a life expectancy of less than six months
* Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
* Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately pre-medicated

Primary outcomes:
measure: Number of Participants Demonstrating Clinical Success at 6 Months
timeFrame: Through 6-month follow-up Visit
measure: Number of Participants With Freedom From Serious Adverse Events at 6 Months
timeFrame: Through 6-month follow-up Visit
Secondary outcomes:
measure: Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg
timeFrame: immediately after deployment
measure: Successful Stent Re-dilation at Re-catheterization
timeFrame: Immediately after re-dilation
measure: Number of Patients With Freedom From Stent Embolization or Migration at 6 Months
timeFrame: 6 months
measure: Number of Patients With Freedom From Stent Fracture at 6 Months
timeFrame: 6 months
measure: Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation
timeFrame: 90 days post re-dilation
measure: Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation
timeFrame: Immediately after re-dilation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Boston
country: United States
facility: Boston Children's
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
city: Memphis
country: United States
facility: Le Bonheur Children's
state: Tennessee
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Hospital Los Angeles
name: Darren Berman, MD
role: PRINCIPAL_INVESTIGATOR
References: