Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing RVOT Reconstruction
This trial is active, not recruiting.
|Condition||heart defects, congenital|
|Treatment||xeltis vascular patch, model cor-vp-001|
|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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
The number of patch related serious adverse events.
time frame: 9 months
Number of subjects with loss of functionality of the patch.
time frame: 9 months
time frame: Histological evaluation of the patch material obtained during the planned reoperation within up to 12 months after implantation
Male or female participants from 2 months up to 16 years old.
1. Patient requiring a bidirectional cava-pulmonary anastomosis
2. Male or Female
3. Age: 2 months to 16 years
1. Main Exclusion Criteria Arrhythmias as determined by ECG and/or at the investigator's
2. Other clinically significant malformations
3. Coagulation disorders as defined by INR outside its normal value, PTT >ULN and
|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.|
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