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Completed

NCT Number: NCT02377700

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

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Age range

2 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakoulev Center for Cardiovascular Surgery

Moscow, 121552, Russia

About this study

Xeltis has developed a medical device for treating pediatric cardiovascular patients requiring RVOT reconstruction. Xeltis' mission is to offer 'Solutions for a Lifetime' to cardiovascular patients. Xeltis has developed a unique technology based on novel biodegradable bio-materials allowing the regrowth of natural heart valves or blood vessels in patients' bodies from their own cells.

The principle of Xeltis' COR technology (COR stands for Cardiovascular Organ Regeneration) is to implant a biodegradable prosthesis of a blood vessels that is shaped like the part to be replaced. The prosthesis is immediately mechanically functional, while its physiochemical characteristics should enable cell infiltration and tissue formation. Tissue is regenerated and functional by the time the polymer is biodegraded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient requiring a bidirectional cava-pulmonary anastomosis
  • Male or Female
  • Age: 2 months to 16 years

Exclusion criteria

  • Main Exclusion Criteria Arrhythmias as determined by ECG and/or at the investigator's discretion
  • Other clinically significant malformations
  • Coagulation disorders as defined by INR outside its normal value, PTT >ULN and Fibrinogen <LLN and/or at the investigator's discretion
  • HIV-infection
  • Syphilis (Treponema pallidum)
  • Hepatitis-B and/or -C virus infection
  • Unwillingness of Parental/legal guardian to give consent
  • Treatment with other investigational products
  • Known or suspected noncompliance, drug or alcohol abuse of the parents/legal guardian
  • Inability of the parents/legal guardian to follow the procedures of the study, e.g. due to language problems
  • Participation of the patient in another study within 30 days preceding and during the present study
  • Previous enrolment of the patient into the current study
  • Enrolment of the investigator's family members, employees and other dependent persons

Treatment and study plan

Xeltis Vascular Patch, Model COR-VP-001

Device

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

Primary outcomes

  1. The Number of Patch Related Serious Adverse Events.

    Time frame: 12 months

    Evaluation of the safety of the COR-VP-001 as defined by number of patients having patch related post-operative complications requiring surgery, intervention or leading to death up to 12 months post implantation

Secondary outcomes

  1. Number of Subjects With Loss of Functionality of the Patch.

    Time frame: 12 months

    Evaluation of the performance of the COR-VP-001 by analyzing the incidence of loss of functionality requiring intervention within up to 12 months post implantation.

  2. Histological Evaluation

    Time frame: up to 12 Months after Implant

    Number of patients with histological evaluation of the patch material obtained during the planned reoperation within up to 12 months after implantation

Sponsors and collaborators

Lead sponsor

Xeltis

Industry

Collaborators

  • Q-Med Scandinavia, Inc.

Registry information

Official study title

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

Acronym: XEL-CR-06

Important dates

Study start
2014
Primary completion
2015
Study completion
2020
First posted
Mar 3, 2015
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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