Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis (XEL-CR-06)

Initial Safety and Performance of the COR-VP-001 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.

Study Overview

• Status: Completed
• Conditions: Heart Defects, Congenital
• Intervention / Treatment: Device: Xeltis Vascular Patch, Model COR-VP-001

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121552
    • Bakoulev Center for Cardiovascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xeltis Vascular Patch, Model COR-VP-001; Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Patch Related Serious Adverse Events.	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Loss of Functionality of the Patch.	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.	12 months
Histological Evaluation	Number of patients with histological evaluation of the patch material obtained during the planned reoperation within up to 12 months after implantation	up to 12 Months after Implant

Collaborators and Investigators

• Sponsor: Xeltis
• Collaborators: Q-Med Scandinavia, Inc.
• Investigators: Principal Investigator: Leo Bockeria, Professor, Bakoulev Center for Cardiovascular Surgery

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: XEL-CR-06