Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis

NACompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2020

Conditions
Heart Defects, Congenital
Interventions
DEVICE

Xeltis Vascular Patch, Model COR-VP-001

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

Trial Locations (1)

121552

Bakoulev Center for Cardiovascular Surgery, Moscow

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Q-Med Scandinavia, Inc.

INDUSTRY

lead

Xeltis

INDUSTRY