Peripheral Arterial DiseaseILLUMENATENCT01858428

Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

A study testing Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter and EverCross Percutaneous Transluminal Balloon Catheter in people with Peripheral Arterial Disease, run by Spectranetics Corporation at 44 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter and EverCross Percutaneous Transluminal Balloon Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 44 sitesin 2 countries
Study dates: 18 Jun 2013to 19 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Who cannot join

Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated

Trial locations and contacts

44 sites in 2 countries.

Country

City, postcode or hospital

44 sites in 2 countries

United States42 sites

Mission Hospital
Asheville, North Carolina, 28801
Emory University Hospital
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30342
Heritage Valley Health System
Beaver, Pennsylvania, 15009
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
CAMC Clinical Trial Center
Charleston, West Virginia, 25304
University of Virginia
Charlottesville, Virginia, 22908
University Surgical Associates
Chattanooga, Tennessee, 37403
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Providence Cardiology LLC
Columbia, South Carolina, 29204
OhioHealth Research Institute
Columbus, Ohio, 43214
Texas Health & Research Education Institution
Dallas, Texas, 75231
Central Iowa Hospital Corporation
Des Moines, Iowa, 50309
El Paso Cardiology Associates
El Paso, Texas, 79902
North Ohio Research LTD.
Elyria, Ohio, 44035
St. Joseph Hospital
Fort Wayne, Indiana, 46802
Mission Cardiovascular Research Institute
Fremont, California, 94538
Cardiovascular Research of North Florida
Gainesville, Florida, 32605
University of Texas Health Science Center
Houston, Texas, 77030
Jackson Heart Clinic
Jackson, Mississippi, 39216
Wellmont Holston Area Medical Center
Kingsport, Tennessee, 37660
Premier Surgical Associates
Knoxville, Tennessee, 37909
Good Samaritan Hospital - Los Angeles
Los Angeles, California, 90017
Medical Center of the Rockies
Loveland, Colorado, 80538
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Aurora Health Care
Milwaukee, Wisconsin, 53215
Yale University School of Medicine
New Haven, Connecticut, 06510
Mount Sinai Medical Center
New York, New York, 10029
Sentara Vascular Specialist
Norfolk, Virginia, 23507
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, 60181
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
Coastal Vascular and Interventional
Pensacola, Florida, 32504
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Providence Heart and Vascular Institute
Portland, Oregon, 97225
Rex Hospital
Raleigh, North Carolina, 27607
Wake Heart Research
Raleigh, North Carolina, 27607
Sanford Health Vascular Associates
Sioux Falls, South Dakota, 57117
Jobst Vascular Institute
Toledo, Ohio, 43606
Pinnacle Health Cardiovascular Institute, INC.
Wormleysburg, Pennsylvania, 17043
Metro Health Hospital
Wyoming, Michigan, 15146
Yuma Regional Medical Center
Yuma, Arizona, 85364

Other trials in United States

Austria2 sites

LKH Univ. - Klinikum Graz
Graz
Hanusch Krankenhaus Wien
Vienna

Other trials in Austria

About this study

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

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.

Read the 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.

Conditions: Peripheral Arterial Disease
Being tested: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, EverCross Percutaneous Transluminal Balloon Catheter
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterDevice
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.
EverCross Percutaneous Transluminal Balloon CatheterDevice
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).

Study groups in NCT01858428
Study group	Role	What they receive
Bare PTA	Active comparator	The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA). Receives: Device: EverCross Percutaneous Transluminal Balloon Catheter
Drug-Coated PTA	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. Receives: Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months
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.
Measured: 30 Days and 12 months

Secondary outcomes (13)

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).
Measured: 1, 6, 12, 24, 36, 48 and 60 months
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.
Measured: in-hospital and 1, 6, 12 and 24 months
Rate of Clinically-driven Target Lesion Revascularization
Measured: 6, 12, 24, 36, 48 and 60 months
Rate of Target Lesion Revascularization
Measured: 6, 12, 24, 36, 48 and 60 months
Rate of Target Limb Major Amputation
Measured: 1, 6, 12, 24, 36, 48 and 60 months
Mortality Rate
Measured: 6, 12, 24, 36, 48 and 60 months
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Measured: 1, 6, 12, 24, 36, 48 and 60 months
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
Measured: 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.
Measured: procedure, Day 0
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.
Measured: procedure, Day 0
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.
Measured: procedure, Day 0
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.
Measured: procedure, Day 0
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.
Measured: 6, 12, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 201319 Mar 2018

First posted21 May 2013 (estimated)
Study start18 Jun 2013
Primary completionSep 2016
Study completion19 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01858428
Sponsor's protocol ID: TP-1397
Acronym: ILLUMENATE
Status last verified: Aug 2020
First submitted: 8 May 2013
Last updated: 24 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020
Krishnan P, Faries P, Niazi K, Sachar R, Jain A, Brodmann M, Werner M, Holden A, Tarricone A, Tarra T, Lyden S. Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial. Am J Cardiol. 2024 Sep 15;227:83-90. doi: 10.1016/j.amjcard.2024.06.027. Epub 2024 Jul 15.
PubMed 39019203
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.
PubMed 34506898
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.
PubMed 31567024
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.
PubMed 28729250

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01858428
Acronym / sponsor ID: ILLUMENATE / TP-1397
Conditions: Peripheral Arterial Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Spectranetics CorporationIndustry (pharma, biotech, devices)
Study start: 18 Jun 2013 (actual)
Primary completion: Sep 2016 (actual)
Study completion: 19 Mar 2018 (actual)
First posted: 21 May 2013 (estimated)
Results: Posted 17 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Bare PTA	Active comparator	Device: EverCross Percutaneous Transluminal Balloon CatheterThe control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
Drug-Coated PTA	Experimental	Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Key exclusion criteria (1 listed)

Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterThe 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.	Device	Drug-Coated PTA
EverCross Percutaneous Transluminal Balloon CatheterThe control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).	Device	Bare PTA

Primary outcome

Patency at 12 Month Post-procedure
Time frame: 12 months
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
Time frame: 30 Days and 12 months
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.

13 secondary outcomes

Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure
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 of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Time frame: procedure, Day 0
Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Time frame: procedure, Day 0
Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure
Time frame: procedure, Day 0
Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure
Time frame: procedure, Day 0
Change in Ankle-brachial Index (ABI) From Pre-procedure
Time frame: 6, 12, 24 and 36 months

Results and safety

Results posted to the registry on 17 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bare PTA	100	99
Drug-Coated PTA	200	190

Primary outcome: Patency at 12 Month Post-procedure

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Bare PTA n = 92	Drug-Coated PTA n = 177
Value	53	135

Population analysed: Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have been eligible for failures carried forward or had a Clinically driven target lesion revasc (CD-TLR) prior to study exit.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Bare PTA n = 95	Drug-Coated PTA n = 189
Value	79	174

Population analysed: Some Safety Status Missing at 12 Months Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have had a primary safety event within 12 months prior to study exit.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bare PTA	63 of 100 (63%)	85 of 100 (85%)	2 of 100
Drug-Coated PTA	120 of 200 (60%)	162 of 200 (81%)	5 of 200

Limitations and caveats (from the sponsor): Per FDA confirmation letter, dated April 10, 2018, Re: G120270/R012, this study concluded March 19, 2018. Subjects rolled into the post-approval study (NCT03421561). Long-term follow-up data can be found there for remaining study objectives.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
Derived from this study: PubMed 39019203Krishnan P, Faries P, Niazi K, Sachar R, Jain A, Brodmann M, Werner M, Holden A, Tarricone A, Tarra T, Lyden S. Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial. Am J Cardiol. 2024 Sep 15;227:83-90. doi: 10.1016/j.amjcard.2024.06.027. Epub 2024 Jul 15.
Derived from this study: PubMed 34506898Lyden 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.
Derived from this study: PubMed 31567024Gray 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.
Derived from this study: PubMed 28729250Krishnan 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.

Related trials for Peripheral Arterial Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prakash Krishnan, MD principal investigator

Mt. Sinai Medical Center

Sean Lyden, MD principal investigator

The Cleveland Clinic

44 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patency at 12 Month Post-procedure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01858428, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.