CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Peripheral Orbital Atherectomy System +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.

Search/NCT02561299
NCT02561299N/ACompleted
CompareCT.gov

Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

Abbott Medical Devices·interventional·Posted Sep 28, 2015·Updated Jul 18, 2023

In Brief

A clinical study evaluating Peripheral Orbital Atherectomy System and 014 Drug Coated Balloon for PAD and Vascular Calcification. Completed, enrolled 66 participants across 7 sites in 2 countries.

Detailed Summary

The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPAD, Vascular Calcification
CountriesAustria, Germany
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 28, 2015
Enrollment StartSep 1, 2015
Primary CompletionJul 2, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.8 years ago

Interventions

Peripheral Orbital Atherectomy Systemdevice

Orbital Atherectomy

014 Drug Coated Balloondevice

Drug Coated Balloon