Growth Trial: Study of the Renata Minima Stent

Coarctation of the Aorta Clinical Trial

Official title:

GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05086016
• Other study ID #: PTC-0009
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: March 30, 2028

Study information

• Verified date: October 2023
• Source: Renata Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: March 30, 2028
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of the Aorta
• Constriction, Pathologic
• Pulmonary Artery Stenosis

Intervention

Device:
• Catheterized Stenting
Catheterized stenting of vascular narrowings.

Locations

Country	Name	City	State
United States	Boston Children's	Boston	Massachusetts
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Nationwide Children's	Columbus	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Le Bonheur Children's	Memphis	Tennessee
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Renata Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SAFETY: Free from stent embolization or migration	Freedom from stent embolization or migration through 6 months.	6 months
Other	SAFETY: Free from Stent Fracture	Freedom from stent fracture that led to reintervention through 6 months	6 months
Other	SAFETY: Free from non-elective Minima Stent explant at 90-days post re-dilation	Freedom from non-elective Minima Stent explant at 90-days post re-dilation	90 days post re-dilation
Other	SAFETY: Freedom from procedure- or device-related SAE during re-dilation	Freedom from procedure- or device-related SAE during re-dilation that results in the following: Death; Cardiac arrest and/or emergency ECMO cannulation; Stroke; Limb loss; Vessel dissection of target lesion; Device thrombosis/occlusion; Cardiac perforation requiring percutaneous or open surgical intervention; Persistent cardiac arrhythmia requiring a pacemaker	Through 6-month follow-up Visit
Primary	Primary Efficacy Endpoint	The primary efficacy endpoint will be assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%.; Clinical success is defined as: Stenosis relief, defined by stent outer diameter = 75% of the surrounding vessel immediately after deployment.; Freedom from open surgical intervention required to treat Minima Stent disfunction through 6 months.; Maintenance of stented vessel diameter = 50% of post-implant diameter at 6 months; as measured using CT angiography and/or angiography.	Through 6-month follow-up Visit
Primary	Primary Safety Endpoint	The primary safety endpoint will be assessed as the percentage of cases with freedom from procedure- or device-related SAEs resulting in an event listed below, with the performance goal defined as greater than 78% of cases: Death; Cardiac arrest and/or emergency ECMO cannulation; Stroke; Limb loss; Vessel dissection of target lesion; Device thrombosis/occlusion; Cardiac perforation requiring percutaneous or open surgical intervention; Persistent cardiac arrhythmia requiring a pacemaker	Through 6-month follow-up Visit
Secondary	Arterial to arterial peak-to-peak pressure gradient to < 20 mmHg	When a pressure gradient provides a reliable hemodynamic variable (e.g., coarctation of the aorta), a reduction in ventricle to arterial or arterial to arterial peak-to-peak pressure gradient to < 20 mmHg after stent placement.	immediately after deployment
Secondary	Successful stent re-dilation at re-catheterization	Successful stent re-dilation (when indicated) at re-catheterization, defined as an increase in the intra stent angiographic luminal diameter within 2mm of the adjacent native vessel diameter immediately after re-dilation.	Immediately after re-dilation