Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
NCT ID: NCT02377674
Last Updated: 2020-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2013-10-31
2020-09-30
Brief Summary
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Xeltis developed a biodegradable prosthesis, the Xeltis Vascular Graft Model COR-VG-001, to be used as an extracardiac conduit between right atrium and the 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-VG-OO is specifically designed to enhance the Fontan surgery outcome by reducing synthetic material related complications and improving hemodynamic characteristics.
Detailed Description
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To address these limitations new generation of biodegradable polymers using recent advances in supramolecular chemistry have been developed to create highly porous vascular grafts allowing efficient cell infiltration following by gradual replacement of the polymer material with the patient's own native-like vascular tissue resulting in full functional restoration. In addition to the ability of reducing postoperative graft-related complications such types of implants have a potential to grow to adapt to the overall body growth and therefore may represent a completely new modality for the treatment of congenital heart disease. In contrast to today's situation with synthetic non-absorbable vascular grafts considered as a "standard of care", where the pediatric patients have to be re-operated several times to adjust the prosthesis size to the somatic growth of the child associated with substantial morbidity and mortality and requiring prolonged anticoagulation treatment, a biodegradable polymer implant could represent a "one-time solution".
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vascular Graft, Model COR-VG-001
A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection.
Vascular Graft, Model COR-VG-001
The intended use of the Xeltis Vascular Graft, Model COR-VG-001 is to create an extracardiac total cavopulmonary connection (EC-TCPC) connection to divert the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle reducing the volume load on the functional single ventricle and thereby improving hemodynamics by minimizing the deleterious effects of ventricular hypertrophy.
Interventions
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Vascular Graft, Model COR-VG-001
The intended use of the Xeltis Vascular Graft, Model COR-VG-001 is to create an extracardiac total cavopulmonary connection (EC-TCPC) connection to divert the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle reducing the volume load on the functional single ventricle and thereby improving hemodynamics by minimizing the deleterious effects of ventricular hypertrophy.
Eligibility Criteria
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Inclusion Criteria
2. Male or Female
3. Aged ≥ 2 years
Exclusion Criteria
2. Pulmonary vascular resistance (PVR) \>3 Wood units as excluded by angiography/cardiac catheterization
3. Moderate or severe atrioventricular (AV) valve regurgitation requiring correction, as determined by echocardiography and/or angiography
4. Moderate or severe outflow valve regurgitation requiring correction as determined by echocardiography and/or angiography
5. Outflow tract (aortic arch and isthmus) obstruction as excluded by:
* a residual outflow gradient of ≥ 20mm Hg or
* requirement of corrective surgery
* as determined by echocardiography and/ or angiography
6. All arrhythmias as determined by ECG and/or at the investigator's discretion
7. Renal dysfunction as excluded by serum creatinine \> ULN and/or urea \>ULN and/or at the investigator's discretion
8. Hepatic dysfunction as excluded by ALT \>ULN, AST \> ULN, GGT \> ULN and/or at the investigator's discretion
9. Coagulation disorders as defined by INR outside its normal value, PTT \>ULN and Fibrinogen \<LLN and/or at the investigator's discretion
10. Transcutaneous O2 saturation \< 65% and/or at the investigator's discretion
11. Immunodeficiency
12. Trisomia 21
13. Asplenia as determined by abdominal ultrasound
14. Heterotaxia as determined by abdominal ultrasound
15. HIV-infection
16. Syphilis (Treponema pallidum)
17. Hepatitis-B and/or -C virus infection
18. Unwillingness of Parental/legal guardian to give consent
19. Contraindications on ethical grounds
20. Treatment with other investigational products
21. Known or suspected non-compliance, drug or alcohol abuse of the parents/legal guardian
22. Inability of the parents/legal guardian to follow the procedures of the study, e.g. due to language problems
23. Participation of the patient in another study within 30 days preceding and during the present study
24. Previous enrollment of the patient into the current study
25. Enrollment of the investigator's family members, employees and other dependent persons
2 Years
18 Years
ALL
No
Sponsors
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Technomics Research
INDUSTRY
Xeltis
INDUSTRY
Responsible Party
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Principal Investigators
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Leo Bockeria, Professor
Role: PRINCIPAL_INVESTIGATOR
Bakoulev Center of Cardiovascular Surgery
Locations
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Bakoulev Center of Cardiovascular Surgery
Moscow, , Russia
Countries
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Other Identifiers
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XEL-CR-05
Identifier Type: -
Identifier Source: org_study_id