CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
Xeltis Vascular Patch, Model COR-VP-001device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02377700
NCT02377700N/ACompleted

Initial Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis

Xeltis·interventional·Posted Mar 3, 2015·Updated Nov 19, 2020

In Brief

A clinical study evaluating Xeltis Vascular Patch, Model COR-VP-001 for Heart Defects, Congenital. Completed, enrolled 5 participants across 1 site.

Detailed Summary

Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. The Xeltis Vascular Graft Model COR-VP-001 is specifically designed to improve surgical outcomes by reducing synthetic material related complications and improving hemodynamic characteristics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 3, 2015
Enrollment StartJun 1, 2014
Primary CompletionSep 1, 2015
Study CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.3 years ago

Interventions

Xeltis Vascular Patch, Model COR-VP-001device

The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis