Heart Defects, CongenitalXEL-CR-06NCT02377700
Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
A study testing Xeltis Vascular Patch, Model COR-VP-001 in people with Heart Defects, Congenital, run by Xeltis at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months to 16 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Xeltis Vascular Patch, Model COR-VP-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
- Jun 2014to 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 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient requiring a bidirectional cava-pulmonary anastomosis
- Male or Female
- Age: 2 months to 16 years
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
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.
Read the detailed 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.
- Conditions
- Heart Defects, Congenital
- Being tested
- Xeltis Vascular Patch, Model COR-VP-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.
Xeltis Vascular Patch, Model COR-VP-001Device
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
| Study group | Role | What they receive |
|---|---|---|
| Xeltis Vascular Patch, Model COR-VP-001 | Experimental | Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis. Receives: Device: Xeltis Vascular Patch, Model COR-VP-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patch Related Serious Adverse Events.
Evaluation of the safety of the COR-VP-001 as defined by number of patients having patch related post-operative complications requiring surgery, intervention or leading to death up to 12 months post implantation
Measured: 12 months
Secondary outcomes (2)
Number of Subjects With Loss of Functionality of the Patch.
Evaluation of the performance of the COR-VP-001 by analyzing the incidence of loss of functionality requiring intervention within up to 12 months post implantation.
Measured: 12 months
Histological Evaluation
Number of patients with histological evaluation of the patch material obtained during the planned reoperation within up to 12 months after implantation
Measured: up to 12 Months after Implant
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 startJun 2014
- 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
- Q-Med Scandinavia, Inc.
- Responsible party
- Sponsor
- Investigators
- Leo Bockeria, Professor, Principal investigator, Bakoulev Center for Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377700
- Sponsor's protocol ID
- XEL-CR-06
- Acronym
- XEL-CR-06
- Status last verified
- Nov 2020
- First submitted
- 18 Feb 2015
- Last updated
- 19 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 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Safety and Performance of the COR-VP-001 Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
- ClinicalTrials.gov ID
- NCT02377700
- Acronym / sponsor ID
- XEL-CR-06 / XEL-CR-06
- Conditions
- Heart Defects, Congenital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Collaborators
- Q-Med Scandinavia, Inc.
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xeltis Vascular Patch, Model COR-VP-001 | Experimental | Device: Xeltis Vascular Patch, Model COR-VP-001Patients implanted with the vascular patch during staged bidirectional cava-pulmonary anastomosis. |
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient requiring a bidirectional cava-pulmonary anastomosis
- Male or Female
- Age: 2 months to 16 years
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| Xeltis Vascular Patch, Model COR-VP-001The 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 | Device | Xeltis Vascular Patch, Model COR-VP-001 |
Primary outcome
The Number of Patch Related Serious Adverse Events.
Time frame: 12 months
Evaluation of the safety of the COR-VP-001 as defined by number of patients having patch related post-operative complications requiring surgery, intervention or leading to death up to 12 months post implantation
2 secondary outcomes
Number of Subjects With Loss of Functionality of the Patch.
Time frame: 12 months
Histological Evaluation
Time frame: up to 12 Months after Implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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 for 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 Xeltis Vascular Patch, Model COR-VP-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 13 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 19 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 19 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 Patch Related Serious Adverse Events. (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 19 Nov 2020.