Nit-Occlud PDA Post-Approval Study | NCT02100683 | Trialant

Nit-Occlud PDA Post-Approval Study | NCT02100683 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PDA Coil	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)
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 Outcomes

Measure	Description	Time Frame
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)

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11066109	Background	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. No abstract available.
30511498	Result	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 percutaneous closure of patent ductus arteriosus. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):645-651. doi: 10.1002/ccd.27995. Epub 2018 Dec 3.

Condition Browse Module