Minima Stent System Post- Approval Study (PAS)

Conditions

• Aortic Coarctation
• Pulmonary Artery Stenosis

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Minima Stent System — DEVICE
  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.

Study Details

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.

Key Dates

Start date

May 21, 2025

Status verified

Oct 2025

Primary completion

May 31, 2027

Completion

Dec 31, 2031

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Minima PAS Patients
  Those treated with the Renata Minima Stent System

Primary Outcome Measure

Rate of Acute Device Success [ Time Frame: End of Procedure (Following Implantation of the Stent) ]

Central Contacts

• Renata Medical Clinical & Regulatory Affairs
  855-318-4988
  [email protected]
• Renata Medical Corporate
  949-478-0539

Locations (15)

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