Ignite Creation Date:
2024-05-05 @ 10:16 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01063712
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2010-02-04
Brief Title:
Safety and Effectiveness of the Device Nit-Occlud PDA-R
Sponsor:
pfm SRL
Organization:
pfm SRL
Study Overview
Official Title:
Safety and Effectiveness of the Device Nit-Occlud PDA-R for Percutaneous Closure of Patent Arterial Duct Between 2 and 8 mm in Patients Treated Interventionally in Specialized Centers
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and the effectiveness of the device Nit-Occlud PDA-R in the percutaneous closure of patent ductus
Detailed Description:
During the years 2003 to 2008 the Cardiological Medical Center Kardiozentrum evaluated 1136 patients with echocardiographic studies 147 of the patients were diagnosed with patent arterial duct The PDA is an abnormal communication between the aorta and pulmonary artery Untreated it can rise the intrapulmonary pressure and lead to serious complications like cardiac insufficiency
The incidence of ducts as an isolated heart disease is between 36 and 7 of all congenital heart diseases at sea level and 10 - 14 at high altitude rising up to 20 in cities at more than 2500 m about sea level The ducts at high altitude are generally wider and larger than at sea level
One treatment alternative is a percutaneous transluminal implantation of a permanent implant which closes the defect The device under investigation Nit-Occlud PDA-R is developed for closure of the PDA with a minimal diameter of 2-8 mm
The device performs the function of generating the defect occlusion by the body itself The implant stimulates the body to generate an epithelium over the implant so that the PDA closes
The incidence of ducts as an isolated heart disease is between 36 and 7 of all congenital heart diseases at sea level and 10 - 14 at high altitude rising up to 20 in cities at more than 2500 m about sea level The ducts at high altitude are generally wider and larger than at sea level
One treatment alternative is a percutaneous transluminal implantation of a permanent implant which closes the defect The device under investigation Nit-Occlud PDA-R is developed for closure of the PDA with a minimal diameter of 2-8 mm
The device performs the function of generating the defect occlusion by the body itself The implant stimulates the body to generate an epithelium over the implant so that the PDA closes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Bioethics Committee | REGISTRY | 08-06-2009 | None |