Overview

This trial is active, not recruiting.

Condition peripheral arterial disease
Treatments cardiovascular ingenuity (cvi) paclitaxel-coated percutaneous transluminal angioplasty balloon catheter, evercross percutaneous transluminal balloon catheter
Sponsor Spectranetics Corporation
Start date June 2013
End date September 2016
Trial size 360 participants
Trial identifier NCT01858428, TP-1397

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
evercross percutaneous transluminal balloon catheter
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
(Experimental)
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.
cardiovascular ingenuity (cvi) paclitaxel-coated percutaneous transluminal angioplasty balloon catheter
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.

Primary Outcomes

Measure
Patency
time frame: 12 months
Freedom from device and procedure-related death and target limb major amputation and clinically-driven target lesion revascularization
time frame: 30 Days and 12 months

Secondary Outcomes

Measure
Major adverse event (MAE) rate
time frame: 1, 6, 12, 24, 36, 48 and 60 months
Rate of vascular access and bleeding complications
time frame: in-hospital and 1, 6, 12 and 24 months
Rate of clinically-driven target lesion revascularization
time frame: 6, 12, 24, 36, 48 and 60 months
Rate of target lesion revascularization
time frame: 6, 12, 24, 36, 48 and 60 months
Rate of target limb major amputation
time frame: 1, 6, 12, 24, 36, 48 and 60 months
Mortality rate
time frame: 6, 12, 24, 36, 48 and 60 months
Rate of occurrence of arterial thrombosis of the treated segment
time frame: 1, 6, 12, 24, 36, 48 and 60 months
Patency rate and freedom from clinically-driven TLR
time frame: 6, 24 and 36 months
Lesion success
time frame: procedure
Technical success
time frame: procedure
Clinical success
time frame: procedure
Procedural success
time frame: procedure
Change in ankle-brachial index (ABI) from pre-procedure
time frame: 6, 12, 24 and 36 months
Change in walking impairment questionnaire (WIQ) from pre-procedure
time frame: 6, 12, 24 and 36 months
Change in walking distance from pre-procedure
time frame: 6, 12, 24 and 36 months
Change in Rutherford-Becker classification of chronic limb ischemia from pre-procedure
time frame: 6, 12, 24 and 36 months
Change in EQ-5D from pre-procedure
time frame: 6, 12, 24 and 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery. Exclusion Criteria: - Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated

Additional Information

Official title 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
Principal investigator Prakash Krishnan, MD
Description The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Spectranetics Corporation.