Clinical trial NCT01858428: Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patency at 12 Month Post-procedure
timeFrame: 12 months
measure: Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
timeFrame: 30 Days and 12 months
Secondary outcomes:
measure: Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure
timeFrame: 1, 6, 12, 24, 36, 48 and 60 months
measure: Rate of Vascular Access and Bleeding Complications
timeFrame: in-hospital and 1, 6, 12 and 24 months
measure: Rate of Clinically-driven Target Lesion Revascularization
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Rate of Target Lesion Revascularization
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Rate of Target Limb Major Amputation
timeFrame: 1, 6, 12, 24, 36, 48 and 60 months
measure: Mortality Rate
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Rate of Occurrence of Arterial Thrombosis of the Treated Segment
timeFrame: 1, 6, 12, 24, 36, 48 and 60 months
measure: Patency Rate and Freedom From Clinically-driven TLR
timeFrame: 6, 24 and 36 months
measure: Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
timeFrame: procedure, Day 0
measure: Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
timeFrame: procedure, Day 0
measure: Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure
timeFrame: procedure, Day 0
measure: Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure
timeFrame: procedure, Day 0
measure: Change in Ankle-brachial Index (ABI) From Pre-procedure
timeFrame: 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital - Los Angeles
state: California
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: Cardiovascular Research of North Florida
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Oakbrook Terrace
country: United States
facility: Advocate Health and Hospitals Corporation
state: Illinois
city: Fort Wayne
country: United States
facility: St. Joseph Hospital
state: Indiana
city: Des Moines
country: United States
facility: Central Iowa Hospital Corporation
state: Iowa
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research LTD.
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Beaver
country: United States
facility: Heritage Valley Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute, INC.
state: Pennsylvania
city: Columbia
country: United States
facility: Providence Cardiology LLC
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health Vascular Associates
state: South Dakota
city: Chattanooga
country: United States
facility: University Surgical Associates
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont Holston Area Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Premier Surgical Associates
state: Tennessee
city: Dallas
country: United States
facility: Texas Health & Research Education Institution
state: Texas
city: El Paso
country: United States
facility: El Paso Cardiology Associates
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Vascular Specialist
state: Virginia
city: Charleston
country: United States
facility: CAMC Clinical Trial Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Graz
country: Austria
facility: LKH Univ. - Klinikum Graz
city: Vienna
country: Austria
facility: Hanusch Krankenhaus Wien
Study officials:
affiliation: Mt. Sinai Medical Center
name: Prakash Krishnan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Sean Lyden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyden SP, Brodmann M, Parikh SA, Krishnan P, Schroeder H, Werner M, Holden A, Ouriel K, Tarra T, Gray WA. Four-year patient-level pooled mortality analysis of the ILLUMENATE US Pivotal and EU randomized controlled trials. J Vasc Surg. 2022 Feb;75(2):600-607. doi: 10.1016/j.jvs.2021.07.244. Epub 2021 Sep 8.
citation: Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.
citation: Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. 2017 Sep 19;136(12):1102-1113. doi: 10.1161/CIRCULATIONAHA.117.028893. Epub 2017 Jul 20.