Heart Defects, Congenital
Conditions
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.
Interventions
DEVICEXeltis 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
Sponsors
Q-Med Scandinavia, Inc.
Xeltis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patch Related Serious Adverse Events. | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Loss of Functionality of the Patch. | 12 months | 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 | up to 12 Months after Implant | Number of patients with histological evaluation of the patch material obtained during the planned reoperation within up to 12 months after implantation |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xeltis Vascular Patch, Model COR-VP-001 Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis.
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 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Xeltis Vascular Patch, Model COR-VP-001 |
|---|---|
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 3.9 years |
| Region of Enrollment Russia | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xeltis Vascular Patch, Model COR-VP-001 | The Number of Patch Related Serious Adverse Events. | 0 Participants |
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
Time frame: up to 12 Months after Implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xeltis Vascular Patch, Model COR-VP-001 | Histological Evaluation | 1 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xeltis Vascular Patch, Model COR-VP-001 | Number of Subjects With Loss of Functionality of the Patch. | 0 Participants |