Trial Outcomes & Findings for Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis (NCT NCT02377700)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

12 months

Results posted on

2020-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xeltis Vascular Patch, Model COR-VP-001 n=5 Participants 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
Age, Categorical <=18 years	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	3.9 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Russia	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Xeltis Vascular Patch, Model COR-VP-001 n=5 Participants 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
The Number of Patch Related Serious Adverse Events.	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Xeltis Vascular Patch, Model COR-VP-001 n=5 Participants 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
Number of Subjects With Loss of Functionality of the Patch.	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Xeltis Vascular Patch, Model COR-VP-001 n=5 Participants 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
Histological Evaluation	1 Participants

Adverse Events

Xeltis Vascular Patch, Model COR-VP-001

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Xeltis Vascular Patch, Model COR-VP-001 n=5 participants at risk 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
Cardiac disorders Stenosis in the bi-directional cava pulmonary anastomosis	20.0% 1/5 • Number of events 1

Other adverse events

Other adverse events
Measure	Xeltis Vascular Patch, Model COR-VP-001 n=5 participants at risk 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
Cardiac disorders Sick sinus syndrome and bundle branch block	20.0% 1/5 • Number of events 1
Cardiac disorders Supraventricular tachycardia and atrial fibrillation	20.0% 1/5 • Number of events 1

Additional Information

Eliane Schutte, CEO

Xeltis

Phone: +31 40 751 7614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place