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

Heart Defects, Congenital Clinical Trial

— XEL-CR-06  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377700
• Other study ID #: XEL-CR-06
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 2020

Study information

• Verified date: November 2020
• Source: Xeltis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2020
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Bakoulev Center for Cardiovascular Surgery	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Xeltis	Q-Med Scandinavia, Inc.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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