Growth Trial: Study of the Renata Minima Stent

Renata Medical

Status: Active, not recruiting

Conditions: Coarctation of the Aorta; Pulmonary Artery Stenosis

Treatments: Device: Catheterized Stenting

Study type: Interventional

Funder types: Industry

Identifiers

NCT05086016

PTC-0009

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

All treated

Experimental group

Description:

The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).

Treatment:

Device: Catheterized Stenting