This trial is active, not recruiting.

Condition heart defects, congenital
Treatment xeltis vascular patch, model cor-vp-001
Sponsor Xeltis AG
Collaborator Q-Med Scandinavia, Inc.
Start date June 2014
End date September 2015
Trial size 5 participants
Trial identifier NCT02377700, XEL-CR-06


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Primary Outcomes

The number of patch related serious adverse events.
time frame: 9 months

Secondary Outcomes

Number of subjects with loss of functionality of the patch.
time frame: 9 months
Histological evaluation
time frame: Histological evaluation of the patch material obtained during the planned reoperation within up to 12 months after implantation

Eligibility Criteria

Male or female participants from 2 months up to 16 years old.

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

Additional Information

Official title Initial Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Principal investigator Leo Bockeria, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Xeltis AG.