Ductus Arteriosus, PatentNCT00828334
NIT-OCCLUD PDA Phase II Sentinel Trial
A study testing Transcatheter PDA Coil in people with Ductus Arteriosus, Patent, run by PFM Medical, Inc at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Ductus Arteriosus, Patent
- What is being tested?
- Transcatheter PDA Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2002to Oct 2007
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- PDA with 4 mm or smaller minimum diameter by color Doppler
- Patent weight > 5 Kg, Age 6 months to 21 years (Patients older than 21 years may have device implant and be included in a study registry.)
- Previous treatment by surgery or Nit-Occlud device with residual PDA noted at least 6 months after the procedure
- Angiographic minimum PDA diameter (D1) less than 4 mm. (Patients with angiographic diameters larger than 4 mm and smaller or equal to 5 mm may have device implant and be included in a study registry.)
Who cannot join
- Associated cardiac anomalies requiring surgery
- Known bleeding or blood clotting disorders
- Ongoing febrile illness
- Pregnancy
- Pulmonary hypertension/increased pulmonary vascular resistance (>5 Wood Units)
- Known hypersensitivity to contrast medium
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Children's Hospital of Akron
Akron, Ohio, 44308
Columbus Children's Hospital
Columbus, Ohio, 43205
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Children's Medical Center of Dallas
Dallas, Texas, 75235
Riley Hospital for Children
Indianapolis, Indiana, 46202-5225
Children's Hospital of Iowa
Iowa City, Iowa, 52242
Mattel Children's Hospital at UCLA
Los Angeles, California, 90095
Children's Hospital Central California
Madera, California, 93638
Hope Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Illinois
Peoria, Illinois, 61603
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Children's Hospital and Regional Medical Center Seattle
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010
A.I. Dupont Hospital for Children
Wilmington, Delaware, 19899
About this study
Official title: Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs.
Read the detailed description
The purpose of this clinical investigation is to evaluate whether transcatheter occlusion of PDAs with a minimum vessel diameter of 4 mm or smaller, by means of permanent implantation of the Nit-Occlud Spiral Coil for PDA Occlusion, is safe and effective.
The device used for this purpose is a set of two items named "Nit-Occlud - PDA Occlusion System":
- Nit-Occlud coils, 2 types: flexible (3 sizes) and medium (3 sizes)
- Introducer Sheath, F4 or F5 85cm.
The intended use of the device is the percutaneous, transluminal closure of PDA with an internal diameter or 4mm and smaller in patients who comply with the selection criteria.
The investigation will continue until the sponsor receives FDA approval for commercial distribution and implantation of the system, or until the project is terminated by the sponsor or by the investigators.
The objectives of this study are:
- To determine the safety of the spiral coil by monitoring and reporting deaths and adverse events associated with the device and device placement.
- To determine the effectiveness of the spiral coil by evaluating clinical and echocardiographic occlusion rates.
- Conditions
- Ductus Arteriosus, Patent
- Being tested
- Transcatheter PDA Coil
- Keywords
- transcatheter occlusion of patent ductus arteriosus
- 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.
Transcatheter PDA CoilDevice
The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter < 4 mm.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter PDA Coil | Experimental | Transcatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA. Receives: Device: Transcatheter PDA Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Performance Criteria (OPC) Technical Success at Implant
Measured: One year
Clinical Closure and Echocardiographic Closure at 12 month follow-up
Measured: One year
Serious Adverse Events and Mortality at 12 months
Measured: One year
Total Device or Procedure Related Adverse Events
Measured: One year
Secondary outcomes (1)
Composite Success. That is technical success, clinical and echocardiographic closure, and absence of device or procedure related death or serious AE at 12 months follow-up
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startNov 2002
- Primary completionJun 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductus Arteriosus, PatentStudies 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
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- PFM Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John W Moore, MD, MPH, Principal investigator, Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828334
- Sponsor's protocol ID
- G010278
- Status last verified
- Mar 2018
- First submitted
- 20 Jan 2009
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
- ClinicalTrials.gov ID
- NCT00828334
- Acronym / sponsor ID
- G010278
- Conditions
- Ductus Arteriosus, Patent
- Keywords
- transcatheter occlusion of patent ductus arteriosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- PFM Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Jan 2009 (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 purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs.
Detailed description
The purpose of this clinical investigation is to evaluate whether transcatheter occlusion of PDAs with a minimum vessel diameter of 4 mm or smaller, by means of permanent implantation of the Nit-Occlud Spiral Coil for PDA Occlusion, is safe and effective.
The device used for this purpose is a set of two items named "Nit-Occlud - PDA Occlusion System":
- Nit-Occlud coils, 2 types: flexible (3 sizes) and medium (3 sizes)
- Introducer Sheath, F4 or F5 85cm.
The intended use of the device is the percutaneous, transluminal closure of PDA with an internal diameter or 4mm and smaller in patients who comply with the selection criteria.
The investigation will continue until the sponsor receives FDA approval for commercial distribution and implantation of the system, or until the project is terminated by the sponsor or by the investigators.
The objectives of this study are:
- To determine the safety of the spiral coil by monitoring and reporting deaths and adverse events associated with the device and device placement.
- To determine the effectiveness of the spiral coil by evaluating clinical and echocardiographic occlusion rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter PDA Coil | Experimental | Device: Transcatheter PDA CoilTranscatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- PDA with 4 mm or smaller minimum diameter by color Doppler
- Patent weight > 5 Kg, Age 6 months to 21 years (Patients older than 21 years may have device implant and be included in a study registry.)
- Previous treatment by surgery or Nit-Occlud device with residual PDA noted at least 6 months after the procedure
- Angiographic minimum PDA diameter (D1) less than 4 mm. (Patients with angiographic diameters larger than 4 mm and smaller or equal to 5 mm may have device implant and be included in a study registry.)
Key exclusion criteria (6 listed)
- Associated cardiac anomalies requiring surgery
- Known bleeding or blood clotting disorders
- Ongoing febrile illness
- Pregnancy
- Pulmonary hypertension/increased pulmonary vascular resistance (>5 Wood Units)
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 |
|---|---|---|
| Transcatheter PDA CoilThe Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter < 4 mm. | Device | Transcatheter PDA Coil |
Primary outcome
Objective Performance Criteria (OPC) Technical Success at Implant
Time frame: One year
Clinical Closure and Echocardiographic Closure at 12 month follow-up
Time frame: One year
Serious Adverse Events and Mortality at 12 months
Time frame: One year
Total Device or Procedure Related Adverse Events
Time frame: One year
1 secondary outcome
Composite Success. That is technical success, clinical and echocardiographic closure, and absence of device or procedure related death or serious AE at 12 months follow-up
Time frame: One year
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 23 Mar 2018.
- 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.
John W Moore, MD, MPH principal investigator
Rady Children's Hospital, San Diego, Department of Pediatrics, UCSD, School of Medicine
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter PDA Coil in people with Ductus Arteriosus, Patent, run by PFM Medical, Inc at 15 sites in United States.
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 4 inclusion and 6 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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?
Objective Performance Criteria (OPC) Technical Success at Implant (time frame: One year). The study lists 4 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 23 Mar 2018.