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

Primary Purpose

Heart Defects, Congenital

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Xeltis Vascular Patch, Model COR-VP-001
Sponsored by
Xeltis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defects, Congenital

Eligibility Criteria

2 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bakoulev Center for Cardiovascular Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xeltis Vascular Patch, Model COR-VP-001

Arm Description

Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2015
Last Updated
November 16, 2020
Sponsor
Xeltis
Collaborators
Q-Med Scandinavia, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02377700
Brief Title
Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Acronym
XEL-CR-06
Official Title
Initial Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xeltis
Collaborators
Q-Med Scandinavia, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xeltis Vascular Patch, Model COR-VP-001
Arm Type
Experimental
Arm Description
Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.
Intervention Type
Device
Intervention Name(s)
Xeltis Vascular Patch, Model COR-VP-001
Intervention Description
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 Outcome Measure Information:
Title
The Number of Patch Related Serious Adverse Events.
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Subjects With Loss of Functionality of the Patch.
Description
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.
Time Frame
12 months
Title
Histological Evaluation
Description
Number of patients with histological evaluation of the patch material obtained during the planned reoperation within up to 12 months after implantation
Time Frame
up to 12 Months after Implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Bockeria, Professor
Organizational Affiliation
Bakoulev Center for Cardiovascular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bakoulev Center for Cardiovascular Surgery
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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