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

NCT ID: NCT02377700

Last Updated: 2020-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Heart Defects, Congenital

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Xeltis Vascular Patch, Model COR-VP-001

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

Group Type EXPERIMENTAL

Xeltis Vascular Patch, Model COR-VP-001

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

2 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Q-Med Scandinavia, Inc.

INDUSTRY

Sponsor Role collaborator

Xeltis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leo Bockeria, Professor

Role: PRINCIPAL_INVESTIGATOR

Bakoulev Center for Cardiovascular Surgery

Locations

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Bakoulev Center for Cardiovascular Surgery

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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XEL-CR-06

Identifier Type: -

Identifier Source: org_study_id