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Trial registered on ANZCTR


Registration number
ACTRN12613000511730
Ethics application status
Approved
Date submitted
2/05/2013
Date registered
8/05/2013
Date last updated
21/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
ILLUMENATE Global (ProspectIve, SingLe-Arm, Global MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon)
Scientific title
ILLUMENATE Global: Prospective, single-arm, global multi-center study to evaluate the safety and performance of the CVI paclitaxel-coated percutaneous angioplasty balloon catheter in the treatment of de novo or restenotic lesions (excluding in-stent lesions) in the superficial and/or popliteal arteries to establish blood flow and to maintain vessel patency.
Secondary ID [1] 282427 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 289034 0
Condition category
Condition code
Cardiovascular 289372 289372 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Intervention code [1] 287073 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289478 0
Primary Safety Endpoint: Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinical driven target lesion revascularization through 12 months post-procedure. Primary Efficacy Endpoint: Primary patency at 12 months post-procedure.
Timepoint [1] 289478 0
Assessed at 12 months post-procedure.
Secondary outcome [1] 302568 0
Major Adverse Event (MAE) rate through discharge and at 1, 6, 12, 24, and 36 months post-procedure, defined as a composite rate of cardiovascular death, major unplanned index limb amputation, and clinical driven target lesion revascularization.
Timepoint [1] 302568 0
1, 6, 12, 24, and 36 months post-procedure
Secondary outcome [2] 302569 0
Rate of adverse events through discharge, and at 1, 6, 12, 24 and 36 months post-procedure, defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects. This definition includes all events related to the investigational medical device and to the procedures involved.
Timepoint [2] 302569 0
1, 6, 12, 24 and 36 months post-procedure
Secondary outcome [3] 302585 0
Rate of clinically-driven target lesion revascularization at 6, 12, 24, and 36 months post-procedure.
Timepoint [3] 302585 0
6, 12, 24, and 36 months post-procedure
Secondary outcome [4] 302586 0
Rate of clinically-driven target vessel revascularization (TVR) at 6, 12, 24, and 36 months post-procedure.
Timepoint [4] 302586 0
6, 12, 24, and 36 months post-procedure
Secondary outcome [5] 302587 0
Rate of major amputation of the target limb at 6, 12, 24 and 36 months post-procedure.
Timepoint [5] 302587 0
6, 12, 24 and 36 months post-procedure
Secondary outcome [6] 302588 0
All-cause mortality rate at 6, 12, 24, and 36 months post-procedure.
Timepoint [6] 302588 0
6, 12, 24, and 36 months post-procedure
Secondary outcome [7] 302589 0
Rate of occurrence of arterial thrombosis of the treated segment at 1, 6, 12, 24, and 36 months post-procedure.
Timepoint [7] 302589 0
1, 6, 12, 24, and 36 months post-procedure
Secondary outcome [8] 302590 0
Rate of ipsilateral embolic events of the study limb within 30 days post-procedure.
Timepoint [8] 302590 0
30 days post-procedure
Secondary outcome [9] 302591 0
Primary patency rate at 6, 24, and 36 months post-procedure. Primary patency is defined as the absence of target lesion restenosis per duplex ultrasound (peak systolic velocity ratio [PSVR] = 2.5) and freedom from clinically-driven target limb revascularization.
Timepoint [9] 302591 0
6, 24, and 36 months post-procedure
Secondary outcome [10] 302592 0
Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of = 50% (per angiographic core lab), after using the investigational device.
Timepoint [10] 302592 0
After using the investigational device
Secondary outcome [11] 302593 0
Technical success, defined as achievement of a final in-lesion residual diameter stenosis of less than or equal to 50% (per angiographic core lab), using the CVI paclitaxel-coated PTA balloon catheter without a device malfunction.
Timepoint [11] 302593 0
After using the investigation device.
Secondary outcome [12] 302594 0
Clinical success (per subject) defined as technical success without the occurrence of major adverse events during procedure.
Timepoint [12] 302594 0
During the procedure.
Secondary outcome [13] 302595 0
Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure.
Timepoint [13] 302595 0
During the procedure.
Secondary outcome [14] 302596 0
Change in Ankle-Brachial Index (ABI) from baseline to 6, 12, 24, and 36 months post-procedure in subjects with compressible arteries and baseline ABI < 0.9.
Timepoint [14] 302596 0
6, 12, 24, and 36 months post-procedure
Secondary outcome [15] 302597 0
Change in Walking Impairment Questionnaire (WIQ) score from baseline to 6, 12, 24, and 36 months post-procedure.
Timepoint [15] 302597 0
6, 12, 24, and 36 months post-procedure
Secondary outcome [16] 302598 0
Change in Rutherford Clinical Category (RCC) from baseline to 6, 12, 24, and 36 months post-procedure.
Timepoint [16] 302598 0
6, 12, 24, and 36 months post-procedure
Secondary outcome [17] 302599 0
Change in EQ-5D from baseline to 6, 12, 24, and 36 months post-procedure.
Timepoint [17] 302599 0
6, 12, 24, and 36 months post-procedure

Eligibility
Key inclusion criteria
General Inclusion Criteria 1. Has clinically significant symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery. 2. Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2-3 subjects should be entered into the study if conservative treatment and/or medicinal therapy have been unsuccessful. 3. Is at least 18 years old. 4. Has life expectancy > 1 year. 5. Is able and willing to provide written informed consent prior to study-specific procedures. 6. Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen. Angiographic Inclusion Criteria 1. Has evidence at the target lesion(s) of clinically and hemodynamically significant de novo stenosis or restenosis, or occlusion, in the SFA (1 cm distal to the ostium of the profunda) and/or popliteal artery, confirmed by angiography. 2. Has target limb with at least one patent (<50% stenosis) tibio-peroneal run-off vessel to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or computed tomography angiography (CTA). Note: Treatment of outflow disease is NOT permitted. 3. Has 1 or 2 target lesion(s) with a cumulative length of no more than 20 cm. 4. Has target lesion(s) located >2 cm from any stent if the target vessel was previously stented. 5. Has a reference vessel diameter of 4 - 6 mm. 6. Has a successful exchangeable guidewire crossing of the lesion(s).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General Exclusion Criteria 1. Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing. 2. Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy 3. Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated. 4. Is currently participating in another investigational device or drug study that would interfere with study endpoints. 5. Has history of hemorrhagic stroke within 3 months. 6. Has surgical or endovascular procedure of the target limb within 14 days prior to the index procedure. 7. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure. 8. Has had a previous peripheral bypass affecting the target limb. 9. Has unstable angina pectoris, myocardial infarction, liver failure, renal failure or chronic kidney disease within 30 days of the index procedure. Angiographic Exclusion Criteria 1. Has significant stenosis (greater than or equal to 50%) or occlusion of inflow tract that is not successfully revascularized (< 30% residual stenosis without death or major vascular complication) prior to treatment of the target lesion(s). Treatment of target lesion(s) is acceptable after successful treatment of inflow artery lesion(s). 2. Has an acute or sub-acute intraluminal thrombus within the target vessel. 3. Has in-stent restenosis or restenosis of the target lesion following previous treatment with a drug-coated balloon. 4. Has an aneurysmal target vessel. 5. Has perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention prior to enrollment. 6. Has no normal arterial segment proximal to the target lesion in which duplex ultrasound velocity ratios can be measured. 7. Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy). 8. Has severe calcification that precludes adequate PTA treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subject is enrolled in the study after he/she has signed the subject informed consent, it has been determined that he/she meets all of the inclusion criteria and none of the exclusion criteria, and the pre-dilatation has been completed. The point of enrollment is defined as the moment the investigational device enters the vasculature.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/07/2013
Actual
23/07/2013
Date of last participant enrolment
Anticipated
30/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment outside Australia
Country [1] 5057 0
New Zealand
State/province [1] 5057 0
Country [2] 5762 0
Belgium
State/province [2] 5762 0

Funding & Sponsors
Funding source category [1] 287202 0
Commercial sector/Industry
Name [1] 287202 0
Covidien
Country [1] 287202 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Covidien
Address
3033 Campus Drive N550
Plymouth, MN 55441
Country
United States of America
Secondary sponsor category [1] 285965 0
None
Name [1] 285965 0
None
Address [1] 285965 0
Country [1] 285965 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289194 0
Health and Disabiltities Ethics Committee
Ethics committee address [1] 289194 0
Ethics committee country [1] 289194 0
New Zealand
Date submitted for ethics approval [1] 289194 0
02/05/2013
Approval date [1] 289194 0
19/06/2013
Ethics approval number [1] 289194 0
13/NTA/84

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39714 0
A/Prof Andrew Holden
Address 39714 0
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Country 39714 0
New Zealand
Phone 39714 0
64 9 3797 440
Fax 39714 0
Email 39714 0
andrewh@adhb.govt.nz
Contact person for public queries
Name 39715 0
Charis Sugden
Address 39715 0
Covidien
3033 Campus Drive N550
Plymouth, MN 55441
Country 39715 0
United States of America
Phone 39715 0
1 763-398-7713
Fax 39715 0
Email 39715 0
charis.sugden@covidien.com
Contact person for scientific queries
Name 39716 0
Charis Sugden
Address 39716 0
Covidien
3033 Campus Drive N550
Plymouth, MN 55441
Country 39716 0
United States of America
Phone 39716 0
1 763-398-7713
Fax 39716 0
Email 39716 0
charis.sugden@covidien.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.