Patent Ductus ArteriosusNCT01479218
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
A study testing Occlutech PDA occluder in people with Patent Ductus Arteriosus, run by Occlutech International AB at 2 sites in 2 countries.
Trial summary
The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types. Read more about this study
- Who is it for?
- Ages 6 months to 70 years
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Occlutech PDA occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2011to May 2014
- 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 6 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a demonstrated patent ductus arteriosus
- Female or male
- Belonging to any ethnic group
- Age between > 6 months and 70 years
- Body weight > 6 kg < 120 kg
Who cannot join
- Associated congenital cardiac anomalies,
- Body weight < 6 Kilograms
- General exclusion criteria
- presence of a known coagulation disorder
- thrombus at the position allocated for the implantation
- a vein thrombosis in the blood vessels chosen for the introducing system
Show all 11Show fewer
- an active infection
- Nitinol intolerance (nickel or titanium)
- contrast medium intolerance
- patients who have a vascular system which is too small to admit the required sheath
- patients with pulmonary hypertension and pulmonary-vascular resistance of >8 Woods Units or a lung - / systemic resistance (PR/SR) of >0.4.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Occlutech PDA occluder
- 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.
Occlutech PDA occluderDevice
Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.
| Study group | Role | What they receive |
|---|---|---|
| PDA Occluder | Other | single arm Receives: Device: Occlutech PDA occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.
Measured: 3 months
Secondary outcomes (1)
Successful closure without evidence of residual shunt after 1 year confirmed by echocariodgram. Safety: freedom of major adverse events i.e periherial embolism or endocarditits.
Measured: 30, 90, 180 and 360 days after implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionMay 2014
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.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ziyad M Hijazi, Professor, Study chair, Rush University medical center, Chicago, USAAlwi Mazeni, Dr, Principal investigator, IJN Heart Institute, Kuala Lumpur, MalaysiaViet Minh Tri Nguyen, Dr, Principal investigator, Pediatric hospital no 2, Hochiminh city, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479218
- Sponsor's protocol ID
- Occlutech-PDA1
- Status last verified
- May 2013
- First submitted
- 18 Nov 2011
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
- ClinicalTrials.gov ID
- NCT01479218
- Acronym / sponsor ID
- Occlutech-PDA1
- Conditions
- Patent Ductus Arteriosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Nov 2011 (estimated)
- 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.
The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDA Occluder | Other | Device: Occlutech PDA occludersingle arm |
Who may qualify
- Ages
- 6 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a demonstrated patent ductus arteriosus
- Female or male
- Belonging to any ethnic group
- Age between > 6 months and 70 years
- Body weight > 6 kg < 120 kg
Key exclusion criteria (11 listed)
- Associated congenital cardiac anomalies,
- Body weight < 6 Kilograms
- General exclusion criteria
- presence of a known coagulation disorder
- thrombus at the position allocated for the implantation
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 |
|---|---|---|
| Occlutech PDA occluderFour different sizes of Occluders will be evaluated based on pre-assessment of PDA size. | Device | PDA Occluder |
Primary outcome
Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.
Time frame: 3 months
1 secondary outcome
Successful closure without evidence of residual shunt after 1 year confirmed by echocariodgram. Safety: freedom of major adverse events i.e periherial embolism or endocarditits.
Time frame: 30, 90, 180 and 360 days after implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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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.
Ziyad M Hijazi, Professor study chair
Rush University medical center, Chicago, USA
Alwi Mazeni, Dr principal investigator
IJN Heart Institute, Kuala Lumpur, Malaysia
Viet Minh Tri Nguyen, Dr principal investigator
Pediatric hospital no 2, Hochiminh city, Vietnam
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlutech PDA occluder in people with Patent Ductus Arteriosus, run by Occlutech International AB at 2 sites in 2 countries.
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 5 inclusion and 11 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia, Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant. (time frame: 3 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 15 Feb 2024.