Nit-Occlud PDA Post-Approval Study

Patent Ductus Arteriosus (PDA) Clinical Trial

Official title:

Nit-Occlud PDA Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100683
• Other study ID #: TP126
• Status: Completed
• Start date: August 2014
• Est. completion date: August 10, 2022

Study information

• Verified date: September 2022
• Source: PFM Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: August 10, 2022
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

Inclusion Criteria:

• Angiographically confirmed PDA with minimum diameter < 4 mm.

• Weight is = 5 kg.

• Age 6 months to 21 years.

Exclusion Criteria:

• Cardiac anomalies requiring surgery.

• Known bleeding or coagulation disorder.

• Febrile illness within 7 days of planned procedure.

• Pregnancy.

• Pulmonary hypertension with increased pulmonary vascular resistance (= 5 Wood Units).

• Hypersensitivity to contrast medium.

• Known nickel allergy.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus (PDA)

Intervention

Device:
• PDA Coil
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Kaiser Permanente	Los Angeles	California
United States	Children's Hospital of Central California	Madera	California
United States	University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
PFM Medical, Inc	Bright Research Partners

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kobayashi D, Salem MM, Forbes TJ, Gordon BM, Soriano BD, Dimas V, Goldstein BH, Owada C, Javois A, Bass J, Jones TK, Berman DP, Gillespie MJ, Moore JW, Levi DS. Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for p — View Citation

Proposed standards for clinical evaluation of patent ductus arteriosus occlusion devices. Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices. Catheter Cardiovasc Interv. 2000 Nov;51(3):293-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety	The primary safety endpoint is to demonstrate the 24-month serious device-related adverse event rate is no worse than the objective-performance criterion (OPC) of 1%.	24 months (2 year)
Primary	Rate of Complete PDA Closure as a Measure of Efficacy	The primary effectiveness endpoint is to demonstrate the 12-month (1 year) complete closure rate for the device is no worse than the OPC of 85%. The closure of the ductus arteriosus will be assessed by absence of residual flow at 12 months (1 year) by transthoracic echocardiogram with 2-D color flow mapping and pulse wave Doppler (ECHO).	12 months (1 year)
Secondary	Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety	The secondary safety endpoint is to demonstrate that the rate of device-related adverse events reported through 24-months post procedure is no worse than 6% (OPC rate of 3% plus an added 3% margin).	24 months (2 year)