NCT06828770

Minima Stent System Post- Approval Study (PAS)

Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Renata Medical · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pulmonary Artery Stenosis
• Aortic Coarctation

Interventions

Type	Name	Description
DEVICE	Minima Stent System	Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight.

Timeline

• Start date: 2025-05-21
• Primary completion: 2027-05-01
• Completion: 2031-12-01
• First posted: 2025-02-14
• Last updated: 2025-10-23

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study