CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 260 enrolled
Drug / intervention
Abre venous self-expanding stent systemdevice
Likely dose
Abre venous self-expanding stent system (9 French Sheath compatible)AI-extracted
Key inclusion· 7
  • ✓Age 18–80 years
  • ✓Clinical manifestation of venous disease: CEAP score ≥3, OR VCSS pain score ≥2, OR suspected DVT
  • ✓Diagnosed non-malignant venous obstruction in common iliac, external iliac, and/or common femoral vein confirmed by venography or IVUS
  • ✓Obstructive lesion: occluded OR ≥50% diameter reduction on venography/IVUS OR ≥50% area reduction on IVUS
Key exclusion· 15
  • ✕DVT in target limb with symptom onset 15 days–6 months prior, or acute DVT elsewhere than target vessel
  • ✕Peripheral arterial disease causing symptoms in target limb
  • ✕Pregnancy or female of child-bearing potential without negative pregnancy test within 7 days of procedure
  • ✕Known or suspected systemic infection at time of procedure

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

Search/NCT03038438
NCT03038438N/ACompleted
CompareCT.gov

A Multi-center, Non-randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction

Medtronic Endovascular·interventional·Posted Jan 31, 2017·Updated Nov 8, 2022

In Brief

A clinical study evaluating Abre venous self-expanding stent system for Iliofemoral Venous Obstruction. Completed, enrolled 260 participants across 24 sites in 6 countries.

Detailed Summary

Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIliofemoral Venous Obstruction
CountriesFrance, Germany, Ireland, Italy, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartDec 13, 2017
Primary CompletionJan 14, 2020
Study CompletionJan 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.4 years ago

Interventions

Abre venous self-expanding stent systemdevice

venous stent