CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Stealth 360°® OASdevice
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/NCT01938391
NCT01938391N/ACompleted
CompareCT.gov

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)

Abbott Medical Devices·interventional·Posted Sep 10, 2013·Updated Jul 18, 2023

In Brief

A clinical study evaluating Stealth 360°® OAS for Peripheral Artery Disease and 4 related conditions. Completed, enrolled 25 participants across 1 site.

Detailed Summary

IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease, PVD
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2013
Enrollment StartJan 1, 2013
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.8 years ago

Interventions

Stealth 360°® OASdevice

Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)