IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

NANot yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 4, 2024

Primary Completion Date

June 4, 2025

Study Completion Date

June 4, 2026

Conditions
Pulmonary Arterial HypertensionDilated CardiomyopathyCongenital Heart Disease
Interventions
DEVICE

IntelliStent

Staged implantation of IntelliStent. The system comprises a nitinol self-expanding stent with a hollow element delivered over-the-wire into the main pulmonary artery or its left and right branches, using an 18 Fr transfemoral introducer sheath. The stent consists of two sections, one with a larger diameter and one with a smaller diameter, available in 6 sizes suitable for vessel sizes ranging from 20mm to 30 mm. Additional smaller sizes are currently under development.

All Listed Sponsors
collaborator

Meditrial USA Inc.

INDUSTRY

lead

HeartPoint Global

INDUSTRY

NCT06072937 - IntelliStent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy | Biotech Hunter | Biotech Hunter