N/A N=5 Treatment

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

Heart Defects, Congenital

Bottom Line

View on ClinicalTrials.gov: NCT02377700 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Nov 2020

Primary outcome: Primary: The Number of Patch Related Serious Adverse Events. — 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Xeltis Vascular Patch, Model COR-VP-001 (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Xeltis
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Patch Related Serious Adverse Events.	—	—
SECONDARY Number of Subjects With Loss of Functionality of the Patch.	—	—
SECONDARY Histological Evaluation	1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02377700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.