At a glance
ClinicalIndex Comparison RecordN/ACompleted· 330 enrolled
Drug / intervention
IN.PACT AV DCB +1 moredevice
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.
Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
In Brief
A clinical study evaluating IN.PACT AV DCB and Standard Balloon Angioplasty for Arteriovenous Fistula Stenosis and 3 related conditions. Completed, enrolled 330 participants across 29 sites in 3 countries.
Detailed Summary
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Arteriovenous Fistula, Fistula
CountriesJapan, New Zealand, United States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartApr 2017
Primary CompletionDec 2018
Study CompletionMay 2023
TodayJul 2026
First PostedFeb 2, 2017
Enrollment StartApr 25, 2017
Primary CompletionDec 6, 2018
Study CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.4 years ago
Interventions
IN.PACT AV DCBdevice
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Standard Balloon Angioplastydevice
Standard PTA Balloon