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

NCT06072937 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-05-16

No results posted yet for this study

Summary

IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in pediatric, adolescent and adult patients with congenital heart disease associated pulmonary arterial hypertension or left ventricular dilated cardiomyopathy.

Conditions

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.

Sponsors & Collaborators

  • Meditrial USA Inc.

    collaborator INDUSTRY

  • HeartPoint Global

    lead INDUSTRY

Principal Investigators

  • Monica Tocchi, MD, PhD · Meditrial USA Inc. Clinical Research Organization

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2025-06-04
Completion
2026-06-04

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072937 on ClinicalTrials.gov