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Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study

NCT04289870 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-07

No results posted yet for this study

Summary

A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System.

Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

Trillium™

Trillium™ Stent Graft for Functional Tricuspid Valve Replacement

Sponsors & Collaborators

  • Innoventric LTD

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2023-07-21
Completion
2026-06-30

Countries

  • Belgium
  • Germany
  • Israel
  • Spain

Study Locations

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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 NCT04289870 on ClinicalTrials.gov