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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01927068




Registration number
NCT01927068
Ethics application status
Date submitted
25/07/2013
Date registered
22/08/2013
Date last updated
24/03/2023

Titles & IDs
Public title
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Scientific title
Prospective, Single-Arm, Global Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery (SFA) and/or Popliteal Lesions With a Novel Paclitaxel-Coated Percutaneous Angioplasty (PTA) Balloon and in In-Stent Restenosis
Secondary ID [1] 0 0
CP-1005B
Secondary ID [2] 0 0
CP-1005
Universal Trial Number (UTN)
Trial acronym
ILLUMENATE
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)

Experimental: Global Cohort 1 - All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).

Experimental: ISR Cohort 2 - All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).


Treatment: Devices: Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
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] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Freedom From Device and Procedure-related Death and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
Timepoint [1] 0 0
Through 12 months post-procedure.
Primary outcome [2] 0 0
Percentage of Lesions Free From Restenosis
Timepoint [2] 0 0
12 months post-procedure.
Secondary outcome [1] 0 0
Secondary Efficacy Endpoint
Timepoint [1] 0 0
12 months post-procedure

Eligibility
Key inclusion criteria
Cohort 1: General

1. Has 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 subjects should be entered into the study if conservative treatment has been unsuccessful.
3. Is =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.

Cohort 1: Angiographic

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 (proximal to the popliteal trifurcation), 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 lesion(s) length of no more than 20 cm. Note: A maximum of two (2) lesions can be treated if the cumulative total lesion length (i.e. the combined length of both lesions) is less than or equal to 20cm.
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 by visual estimate.
6. Has a successful exchangeable guidewire crossing of the lesion(s).

Cohort 1: General
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A female who is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing; or a male intending to father children during the study.
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 (dialysis dependent, or serum creatinine =2.5 mg/dL) within 30 days of the index procedure.

Cohort 1: Angiographic

1. Has significant stenosis (=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). Only treatment of target lesion(s) is acceptable after successful treatment of inflow iliac 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 aneurysm (at least twice the reference vessel diameter) located in the target vessel, abdominal aorta, iliac, or popliteal arteries.
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.

Cohort 2: General Inclusion Criteria:

1. Has 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 subjects should be entered into the study if conservative treatment has been unsuccessful.
3. Is between 18-85 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.
7. History of previous femoropopliteal nitinol stenting which is suspect for in-stent restenosis.
8. The patient has a resting ankle-brachial index (ABI) <0.9 or an abnormal exercise ABI (<0.9) if resting ABI is normal. Patient with incompressible arteries (ABI>1.2) must have a toe-brachial index (TBI) <0.7 in target limb.

Cohort 2: Angiographic Inclusion Criteria:

1. Has angiographic evidence of significant restenosis (=50% by visual estimate) within a previously deployed femoropopliteal bare nitinol stent(s) including ISR Class I, II or III.
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. Total target treatment length of in-stent restenosis must be =4.0 cm in length and may include a single lesion or a multifocal lesion within the femoropopliteal segment (This includes the proximal, mid, and/or distal SFA and PI, P2 and/or P3 segment of the popliteal artery). Edge restenosis may be treated provided the lesion extends no more than 3 cm outside the margin of the stent (proximal and/or distal margin).
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 by visual estimate.
6. Has a successful exchangeable guidewire crossing of the lesion(s).

Cohort 2: General

1. A female who is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing; or a male intending to father children during the study.
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 including those within <60 days with an unresolved walking impairment.
6. Has surgical or endovascular procedure of the target limb within 3 months 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 within 60 days, liver failure, renal failure or chronic kidney disease (dialysis dependent, or serum creatinine =2.5 mg/dL) within 30 days of the index procedure.
10. History of previous femoropopliteal stenting in the target lesion with drug eluting stents or covered stents (endografts).

Cohort 2: Angiographic

1. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis

=50% diameter stenosis (DS) that is not successfully treated prior to index procedure (e.g. where a perforation occurred requiring a covered stent) or with final residual stenosis = 30% documented by angiography.
2. Identification of any lesion of the native vessel (excludes ISR) above the target stent in the femoropopliteal segment >50% that is not successfully treated prior to index procedure (e.g. complication requiring additional treatment) or with final residual stenosis >30% documented by angiography. Drug eluting stent (DES) and drug coated balloon (DCB) will not be allowed. The lesion length must be treatable with a single stent (if required). The lesion must not be contiguous with the target lesion; at least 2 cm of normal appearing vessel between the lesion and target lesion/ target stent or between deployed stent (if required) and the target lesion/ target stent.
3. Has an acute or sub-acute intraluminal thrombus within the target vessel.
4. Has an aneurysm (at least twice the reference vessel diameter) located in the target vessel, abdominal aorta, iliac, or popliteal arteries.
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. Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2022
Sample size
Target
Accrual to date
Final
499
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Wesley St. Andrew Research Institute Ltd. - Auchenflower
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Monash Medical Centre at Dandenong Campus - Dandenong
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Bedford
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
3175 - Dandenong
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Belgium
State/province [2] 0 0
Aalst
Country [3] 0 0
Belgium
State/province [3] 0 0
Antwerpen
Country [4] 0 0
Belgium
State/province [4] 0 0
Bonheiden
Country [5] 0 0
Belgium
State/province [5] 0 0
Dendermonde
Country [6] 0 0
Belgium
State/province [6] 0 0
Genk
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Tienen
Country [10] 0 0
France
State/province [10] 0 0
Clermont-Ferrand
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
France
State/province [13] 0 0
Nantes
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Rennes
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
Germany
State/province [17] 0 0
Bad Krozingen
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Heidelberg
Country [20] 0 0
Germany
State/province [20] 0 0
Immenstadt
Country [21] 0 0
Germany
State/province [21] 0 0
Langensteinbach
Country [22] 0 0
Germany
State/province [22] 0 0
Leipzig
Country [23] 0 0
Germany
State/province [23] 0 0
Rosenheim
Country [24] 0 0
Germany
State/province [24] 0 0
Tübingen
Country [25] 0 0
Italy
State/province [25] 0 0
Ancona
Country [26] 0 0
Italy
State/province [26] 0 0
Palermo
Country [27] 0 0
Italy
State/province [27] 0 0
Perugia
Country [28] 0 0
New Zealand
State/province [28] 0 0
Auckland
Country [29] 0 0
New Zealand
State/province [29] 0 0
Hamilton
Country [30] 0 0
New Zealand
State/province [30] 0 0
Wellington
Country [31] 0 0
Poland
State/province [31] 0 0
Gdansk
Country [32] 0 0
Poland
State/province [32] 0 0
Warszawa
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spectranetics Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries.

Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.
Trial website
https://clinicaltrials.gov/study/NCT01927068
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Zeller, MBChB, FRANZCR
Address 0 0
Herz-Zentrum Bad Krozingen, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01927068