Heart Defects, CongenitalEC-TCPCNCT02377674
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
A study testing Vascular Graft, Model COR-VG-001 in people with Heart Defects, Congenital, run by Xeltis at 1 site in Russia.
Trial summary
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Vascular Graft, Model COR-VG-001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2013to Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient requiring EC-TCPC
- Male or Female
- Aged ≥ 2 years
Who cannot join
- Pulmonary artery pressure (PAP) > 15 mm Hg as excluded by angiography/cardiac catheterization
- Pulmonary vascular resistance (PVR) >3 Wood units as excluded by angiography/cardiac catheterization
- Moderate or severe atrioventricular (AV) valve regurgitation requiring correction, as determined by echocardiography and/or angiography
- Moderate or severe outflow valve regurgitation requiring correction as determined by echocardiography and/or angiography
- Outflow tract (aortic arch and isthmus) obstruction as excluded by:
- a residual outflow gradient of ≥ 20mm Hg or
Show all 28Show fewer
- requirement of corrective surgery
- as determined by echocardiography and/ or angiography
- All arrhythmias as determined by ECG and/or at the investigator's discretion
- Renal dysfunction as excluded by serum creatinine > ULN and/or urea >ULN and/or at the investigator's discretion
- Hepatic dysfunction as excluded by ALT >ULN, AST > ULN, GGT > ULN and/or at the investigator's discretion
- Coagulation disorders as defined by INR outside its normal value, PTT >ULN and Fibrinogen <LLN and/or at the investigator's discretion
- Transcutaneous O2 saturation < 65% and/or at the investigator's discretion
- Immunodeficiency
- Trisomia 21
- Asplenia as determined by abdominal ultrasound
- Heterotaxia as determined by abdominal ultrasound
- HIV-infection
- Syphilis (Treponema pallidum)
- Hepatitis-B and/or -C virus infection
- Unwillingness of Parental/legal guardian to give consent
- Contraindications on ethical grounds
- Treatment with other investigational products
- Known or suspected non-compliance, 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 enrollment of the patient into the current study
- Enrollment of the investigator's family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess the Initial Safety and Performance of COR-VG-001 Conduit in Pediatric Patients Undergoing Extracardiac Total Cavopulmonary Connection (EC-TCPC)
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle. In the extracardiac conduit type of Fontan, one end of a synthetic tube graft is connected to the inferior vena cava and the other end to the pulmonary artery confluence.
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.
Read the detailed description
Although significant progress has been made in recent years in the field of congenital heart disease treatment, a substantial unmet clinical need remains for implantable materials/devices such as vascular grafts and heart valves with improved long-term performance and reduced device-related complications.
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
- Heart Defects, Congenital
- Being tested
- Vascular Graft, Model COR-VG-001
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Graft, Model COR-VG-001Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Vascular Graft, Model COR-VG-001 | Experimental | A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection. Receives: Device: Vascular Graft, Model COR-VG-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation.
Evaluation of the safety of the COR-VG-001 as defined by numbers of patients having graft related post-operative complications requiring surgery, intervention or leading to death within 12-month post implantation
Measured: 12 months
Secondary outcomes (1)
The Number of Grafts That Have a Reduced Function Post Operatively.
Evaluation of the performance of the COR-VG-01 by analyzing, with the help of echocardiography, the incidence of loss of functionality requiring intervention within 12 months post implantation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Technomics Research
- Responsible party
- Sponsor
- Investigators
- Leo Bockeria, Professor, Principal investigator, Bakoulev Center of Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377674
- Sponsor's protocol ID
- XEL-CR-05
- Acronym
- EC-TCPC
- Status last verified
- Oct 2020
- First submitted
- 18 Feb 2015
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Initial Safety and Performance of COR-VG-001 Conduit in Pediatric Patients Undergoing Extracardiac Total Cavopulmonary Connection (EC-TCPC)
- ClinicalTrials.gov ID
- NCT02377674
- Acronym / sponsor ID
- EC-TCPC / XEL-CR-05
- Conditions
- Heart Defects, Congenital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Collaborators
- Technomics Research
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 10 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle. In the extracardiac conduit type of Fontan, one end of a synthetic tube graft is connected to the inferior vena cava and the other end to the pulmonary artery confluence.
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
Although significant progress has been made in recent years in the field of congenital heart disease treatment, a substantial unmet clinical need remains for implantable materials/devices such as vascular grafts and heart valves with improved long-term performance and reduced device-related complications.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular Graft, Model COR-VG-001 | Experimental | Device: Vascular Graft, Model COR-VG-001A surgically implanted vascular graft for pediatric patients undergoing extracardiac total cavopulmonary connection. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient requiring EC-TCPC
- Male or Female
- Aged ≥ 2 years
Key exclusion criteria (28 listed)
- Pulmonary artery pressure (PAP) > 15 mm Hg as excluded by angiography/cardiac catheterization
- Pulmonary vascular resistance (PVR) >3 Wood units as excluded by angiography/cardiac catheterization
- Moderate or severe atrioventricular (AV) valve regurgitation requiring correction, as determined by echocardiography and/or angiography
- Moderate or severe outflow valve regurgitation requiring correction as determined by echocardiography and/or angiography
- Outflow tract (aortic arch and isthmus) obstruction as excluded by:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular Graft, Model COR-VG-001The 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. | Device | Vascular Graft, Model COR-VG-001 |
Primary outcome
The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation.
Time frame: 12 months
Evaluation of the safety of the COR-VG-001 as defined by numbers of patients having graft related post-operative complications requiring surgery, intervention or leading to death within 12-month post implantation
1 secondary outcome
The Number of Grafts That Have a Reduced Function Post Operatively.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leo Bockeria, Professor principal investigator
Bakoulev Center of Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Graft, Model COR-VG-001 in people with Heart Defects, Congenital, run by Xeltis at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Graft Related Post-operative Complications That Require a Repeat Surgery or a Non Surgical Treatment Within 12-month Post Implantation. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.