Clinical trial NCT02377700: Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Official title: Initial Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Lead sponsor: Xeltis
Sponsor class: INDUSTRY
Collaborators: name: Q-Med Scandinavia, Inc.
First posted: 2015-03-03
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Patch Related Serious Adverse Events.
timeFrame: 12 months
Secondary outcomes:
measure: Number of Subjects With Loss of Functionality of the Patch.
timeFrame: 12 months
measure: Histological Evaluation
timeFrame: up to 12 Months after Implant
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Bakoulev Center for Cardiovascular Surgery
Study officials:
affiliation: Bakoulev Center for Cardiovascular Surgery
name: Leo Bockeria, Professor
role: PRINCIPAL_INVESTIGATOR
References: