Patent Ductus ArteriosusNCT04291222
Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
A study testing Iron biocorrodable coronary scaffold system in people with Patent Ductus Arteriosus and Duct-dependent Cyanotic Congenital Heart Disease, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Malaysia.
Trial summary
This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent implantation in the PDA as initial palliation of cyanotic CHD with duct-dependent PBF. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Patent Ductus Arteriosus, Duct-dependent Cyanotic Congenital Heart Disease
- What is being tested?
- Iron biocorrodable coronary scaffold system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMalaysia
- Study dates
- 11 Dec 2018to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight >3.0 kg
- Age <3 months
- Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight
Who cannot join
- Weight <3 kg, age >3 months
- Angiographic criteria-tortuous PDA
- Family history of diseases related to iron overload or iron disorder e.g. hereditary hemochromatosis
- Other severe congenital anomalies with life expectancy <12 months
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent implantation in the PDA as initial palliation of cyanotic CHD with duct-dependent PBF.
Read the detailed description
Study type: Interventional, prospective, single arm, investigator initiated Study population: 10 patients Primary purpose: Treatment Follow up: Review at 1 month and thereafter 3 monthly (clinical examination and echocardiography for stent patency, SaO2 measurement. Serum Iron and Ferritin levels will be measured before procedure and at follow ups. From 6 months onwards the patients will be assessed for the need of repeat catheterization with a view of surgery or for continued observation.
Study endpoints: 9 months post implant or the following: 1)Patients are subjected for surgical repair of CHD; 2)Death before surgical repair; 3)Unplanned re-intervention with additional stenting procedure.
- Being tested
- Iron biocorrodable coronary scaffold system
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron biocorrodable coronary scaffold systemDevice
Implantation of Iron biocorrodable coronary scaffold system
| Study group | Role | What they receive |
|---|---|---|
| IBS implantation | Experimental | Implantation of IBS in PDA in duct-dependent cyanotic CHD Receives: Device: Iron biocorrodable coronary scaffold system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants for surgical repair of CHD
Patients are subjected for surgical repair of CHD
Measured: 9 months
Number of Unplanned re-intervention
Unplanned re-intervention with additional stenting procedure
Measured: 9 months
Death
Death before surgical repair
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start11 Dec 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291222
- Sponsor's protocol ID
- IBS-AngelV1.0
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
- ClinicalTrials.gov ID
- NCT04291222
- Acronym / sponsor ID
- IBS-AngelV1.0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent implantation in the PDA as initial palliation of cyanotic CHD with duct-dependent PBF.
Detailed description
Study type: Interventional, prospective, single arm, investigator initiated Study population: 10 patients Primary purpose: Treatment Follow up: Review at 1 month and thereafter 3 monthly (clinical examination and echocardiography for stent patency, SaO2 measurement. Serum Iron and Ferritin levels will be measured before procedure and at follow ups. From 6 months onwards the patients will be assessed for the need of repeat catheterization with a view of surgery or for continued observation.
Study endpoints: 9 months post implant or the following: 1)Patients are subjected for surgical repair of CHD; 2)Death before surgical repair; 3)Unplanned re-intervention with additional stenting procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| IBS implantation | Experimental | Device: Iron biocorrodable coronary scaffold systemImplantation of IBS in PDA in duct-dependent cyanotic CHD |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Weight >3.0 kg
- Age <3 months
- Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight
Key exclusion criteria (4 listed)
- Weight <3 kg, age >3 months
- Angiographic criteria-tortuous PDA
- Family history of diseases related to iron overload or iron disorder e.g. hereditary hemochromatosis
- Other severe congenital anomalies with life expectancy <12 months
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 |
|---|---|---|
| Iron biocorrodable coronary scaffold systemImplantation of Iron biocorrodable coronary scaffold system | Device | IBS implantation |
Primary outcome
Number of participants for surgical repair of CHD
Time frame: 9 months
Patients are subjected for surgical repair of CHD
Number of Unplanned re-intervention
Time frame: 9 months
Unplanned re-intervention with additional stenting procedure
Death
Time frame: 9 months
Death before surgical repair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron biocorrodable coronary scaffold system in people with Patent Ductus Arteriosus and Duct-dependent Cyanotic Congenital Heart Disease, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Malaysia.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Mar 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 Malaysia. 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?
Results are not available in the source record.
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?
Number of participants for surgical repair of CHD (time frame: 9 months). The study lists 3 primary outcomes in all. 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 2 Mar 2020.