CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Nit-Occlud® PDA-Rdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01063712
NCT01063712Phase 2Completed
CompareCT.gov

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

pfm S.R.L.·interventional·Posted Feb 5, 2010·Updated May 24, 2012

In Brief

A Phase 2 clinical trial evaluating Nit-Occlud® PDA-R for Congenital Heart Disease. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease
CountriesBolivia
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2010
Enrollment StartJun 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.4 years ago

Interventions

Nit-Occlud® PDA-Rdevice

Transcatheter implantation of a PDA Device (Nitinol) The catheterism was done under sedation, using a protocol established by inserting a catheter through a femoral artery and/or vein directed to the heart and great vessels. Invasive measurements are obtained in the descending aorta and pulmonary artery. Once in ductal position, we inject iodinated contrast medium that allows us to observe via X-ray the ductal morphology; obtaining accurate measurements to choose the appropriate device. The device is then inserted via the catheter, closing the ductus. The catheterism provides measures of aortic and pulmonary pressure, before, during and after the closure.