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Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon (ILLUMENATE)

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
EverCross Percutaneous Transluminal Balloon Catheter
Sponsored by
Spectranetics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yuma Regional Medical Center
  • Mission Cardiovascular Research Institute
  • Good Samaritan Hospital - Los Angeles
  • Medical Center of the Rockies
  • Yale University School of Medicine
  • Cardiovascular Research of North Florida
  • Baptist Cardiac and Vascular Institute
  • Coastal Vascular and Interventional
  • Emory University Hospital
  • Northside Hospital
  • Advocate Health and Hospitals Corporation
  • St. Joseph Hospital
  • Central Iowa Hospital Corporation
  • Cardiac & Vascular Research Center of Northern Michigan
  • Metro Health Hospital
  • Jackson Heart Clinic
  • Deborah Heart and Lung Center
  • Mount Sinai Medical Center
  • Mission Hospital
  • Rex Hospital
  • Wake Heart Research
  • Cleveland Clinic Foundation
  • OhioHealth Research Institute
  • North Ohio Research LTD.
  • Jobst Vascular Institute
  • Oklahoma Foundation for Cardiovascular Research
  • Providence Heart and Vascular Institute
  • Heritage Valley Health System
  • University of Pittsburgh Medical Center
  • Pinnacle Health Cardiovascular Institute, INC.
  • Providence Cardiology LLC
  • Sanford Health Vascular Associates
  • University Surgical Associates
  • Wellmont Holston Area Medical Center
  • Premier Surgical Associates
  • Texas Health & Research Education Institution
  • El Paso Cardiology Associates
  • University of Texas Health Science Center
  • University of Virginia
  • Sentara Vascular Specialist
  • CAMC Clinical Trial Center
  • Aurora Health Care
  • LKH Univ. - Klinikum Graz
  • Hanusch Krankenhaus Wien

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bare PTA

Drug-Coated PTA

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Patency at 12 Month Post-procedure
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.

Secondary Outcome Measures

Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure
Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Rate of Vascular Access and Bleeding Complications
Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.
Rate of Clinically-driven Target Lesion Revascularization
Rate of Target Lesion Revascularization
Rate of Target Limb Major Amputation
Mortality Rate
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Patency Rate and Freedom From Clinically-driven TLR
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months
Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.
Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.
Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure
Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.
Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure
Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.
Change in Ankle-brachial Index (ABI) From Pre-procedure
Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.

Full Information

First Posted
May 8, 2013
Last Updated
August 10, 2020
Sponsor
Spectranetics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01858428
Brief Title
Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
Acronym
ILLUMENATE
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 18, 2013 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
March 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectranetics Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bare PTA
Arm Type
Active Comparator
Arm Description
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
Arm Title
Drug-Coated PTA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
EverCross Percutaneous Transluminal Balloon Catheter
Intervention Description
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
Primary Outcome Measure Information:
Title
Patency at 12 Month Post-procedure
Description
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Time Frame
12 months
Title
Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
Description
Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.
Time Frame
30 Days and 12 months
Secondary Outcome Measure Information:
Title
Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure
Description
Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time Frame
1, 6, 12, 24, 36, 48 and 60 months
Title
Rate of Vascular Access and Bleeding Complications
Description
Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.
Time Frame
in-hospital and 1, 6, 12 and 24 months
Title
Rate of Clinically-driven Target Lesion Revascularization
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Rate of Target Lesion Revascularization
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Rate of Target Limb Major Amputation
Time Frame
1, 6, 12, 24, 36, 48 and 60 months
Title
Mortality Rate
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Time Frame
1, 6, 12, 24, 36, 48 and 60 months
Title
Patency Rate and Freedom From Clinically-driven TLR
Description
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months
Time Frame
6, 24 and 36 months
Title
Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Description
Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.
Time Frame
procedure, Day 0
Title
Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Description
Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.
Time Frame
procedure, Day 0
Title
Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure
Description
Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.
Time Frame
procedure, Day 0
Title
Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure
Description
Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.
Time Frame
procedure, Day 0
Title
Change in Ankle-brachial Index (ABI) From Pre-procedure
Description
Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.
Time Frame
6, 12, 24 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prakash Krishnan, MD
Organizational Affiliation
Mt. Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean Lyden, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuma Regional Medical Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
Mission Cardiovascular Research Institute
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Good Samaritan Hospital - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Cardiovascular Research of North Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Coastal Vascular and Interventional
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Advocate Health and Hospitals Corporation
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
St. Joseph Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46802
Country
United States
Facility Name
Central Iowa Hospital Corporation
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Cardiac & Vascular Research Center of Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
15146
Country
United States
Facility Name
Jackson Heart Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Heart Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
North Ohio Research LTD.
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Jobst Vascular Institute
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Oklahoma Foundation for Cardiovascular Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Providence Heart and Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Heritage Valley Health System
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute, INC.
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Providence Cardiology LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Sanford Health Vascular Associates
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
University Surgical Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Wellmont Holston Area Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Premier Surgical Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Health & Research Education Institution
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
El Paso Cardiology Associates
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Vascular Specialist
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
CAMC Clinical Trial Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
LKH Univ. - Klinikum Graz
City
Graz
Country
Austria
Facility Name
Hanusch Krankenhaus Wien
City
Vienna
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
34506898
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.
Results Reference
derived
PubMed Identifier
31567024
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.
Results Reference
derived
PubMed Identifier
28729250
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.
Results Reference
derived

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Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

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