Minima Stent System Post- Approval Study (PAS)

Renata Medical

Status

Not yet enrolling

Conditions

Pulmonary Artery Stenosis

Aortic Coarctation

Treatments

Device: Minima Stent System

Study type

Observational

Funder types

Industry

Identifiers

NCT06828770

PTC-0038

Details and patient eligibility

About

This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.

Full description

A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
Indicated for treatment with the Minima Stent System per the IFU.

Exclusion criteria

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 premedicated