CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter +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/NCT01858428
NCT01858428N/ACompleted
CompareCT.gov

ILLUMENATE Pivotal: ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon

Spectranetics Corporation·interventional·Posted May 21, 2013·Updated Aug 24, 2020

In Brief

A clinical study evaluating Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter and EverCross Percutaneous Transluminal Balloon Catheter for Peripheral Arterial Disease. Completed, enrolled 300 participants across 44 sites in 2 countries.

Detailed Summary

This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesAustria, United States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 21, 2013
Enrollment StartJun 18, 2013
Primary CompletionSep 1, 2016
Study CompletionMar 19, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.1 years ago

Interventions

Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheterdevice

The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.

EverCross Percutaneous Transluminal Balloon Catheterdevice

The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).