At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 217 enrolled
Drug / intervention
ArterX Surgical Sealant +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.
A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.
In Brief
A Phase 3 clinical trial evaluating ArterX Surgical Sealant and Gelfoam and Thrombin for Vascular Disease. Completed, enrolled 217 participants across 1 site.
Detailed Summary
This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels using synthetic vascular grafts or patches.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVascular Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionDec 2009
Study CompletionMar 2010
TodayJul 2026
First PostedSep 25, 2008
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.8 years ago
Interventions
ArterX Surgical Sealantdevice
Apply at the suture site.
Gelfoam and Thrombindevice
Apply at the suture site.