Peripheral Artery DiseaseNCT03421561
ILLUMENATE Pivotal Post-Approval Study (PAS)
A study testing Stellarex 0.035" OTW Drug-coated Angioplasty Balloon and EverCross™ 0.035 PTA Balloon Catheter in people with Peripheral Artery Disease, run by Spectranetics Corporation at 41 sites in 2 countries.
Trial summary
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Stellarex 0.035" OTW Drug-coated Angioplasty Balloon and EverCross™ 0.035 PTA Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 41 sitesin 2 countries
- Study dates
- 18 Jun 2013to 6 Oct 2020
- 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
None listed.
Who cannot join
- Subject with any of the following clinical criteria should be excluded:
- Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.
- Known aortic aneurysm(s) > 5 cm.
- Contraindication to dual anti-platelet therapy.
- Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
- Current participation in an investigational drug or another device study.
Show all 23Show fewer
- History of hemorrhagic stroke within 3 months.
- Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
- Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion.
- Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.
- Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.
- Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure).
- Subject with any of the following angiographic criteria should be excluded:
- Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.
- No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.
- Known inadequate distal outflow.
- Acute or sub-acute thrombus in the target vessel.
- Aneurysmal target vessel.
- Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.
- Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment).
- Presence of concentric calcification that precludes PTA pre-dilation.
- Prior stent placement in the target vessel.
- Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States39 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
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
Houston, Texas, 77030
Jackson Heart Clinic
Jackson, Mississippi, 39216
Wellmont Holston Valley Medical
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
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
Wake Heart Research
Raleigh, North Carolina, 19010
Rex Hospital
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
About this study
Official title: 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 Pivotal Post-Approval Study
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
Read the detailed description
The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB.
Each enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.
- Conditions
- Peripheral Artery Disease
- Being tested
- Stellarex 0.035" OTW Drug-coated Angioplasty Balloon, EverCross™ 0.035 PTA 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.
Stellarex 0.035" OTW Drug-coated Angioplasty BalloonDevice
The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
EverCross™ 0.035 PTA Balloon CatheterDevice
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
| Study group | Role | What they receive |
|---|---|---|
| DCB Subjects | Experimental | The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
Basic Catheter Specifications
* Guidewire: 0.035"
* Balloon Length: 40/80/120 mm
* Sheath Compatibility: greater than or equal to 6 French
* Balloon Diameter: 4/5/6 mm
* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Receives: Device: Stellarex 0.035" OTW Drug-coated Angioplasty Balloon |
| PTA Subjects | Placebo comparator | The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Basic Catheter Specifications
* Guidewire: 0.035"
* Balloon Length: 40/80/120 mm
* Sheath Compatibility: greater to or equal to 6 French
* Balloon Diameter: 4/5/6 mm
* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. Receives: Device: EverCross™ 0.035 PTA Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Target Vessel Patency at 24 Months 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: 24 months post-procedure
Number of Participants With 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 24 Months Post-procedure
The primary safety outcome is defined as 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 (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).
Measured: 24 months post-procedure
Secondary outcomes (42)
Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Measured: 24 months post-procedure
Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Measured: 36 months post-procedure
Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Measured: 48 months post-procedure
Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Measured: 60 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Measured: 24 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Measured: 36 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Measured: 48 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Measured: 60 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Measured: 24 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Measured: 36 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Measured: 48 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Measured: 60 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Measured: 24 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Measured: 36 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Measured: 48 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Measured: 60 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Measured: 24 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Measured: 36 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Measured: 48 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Measured: 60 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Measured: 24 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Measured: 36 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Measured: 48 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Measured: 60 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Measured: 24 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Measured: 36 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Measured: 48 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Measured: 60 months post-procedure
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) 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
Measured: 24 months post-procedure
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) 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
Measured: 36 months post-procedure
Change in Ankle-brachial Index (ABI) From Pre-procedure
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Measured: 24 months post-procedure
Change in Ankle-brachial Index (ABI) From Pre-procedure
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Measured: 36 months post-procedure
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
Measured: 24 months post-procedure
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
Measured: 36 months post-procedure
Change in Walking Distance From Pre-procedure
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.
Measured: 24 months post-procedure
Change in Walking Distance From Pre-procedure
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.
Measured: 36 months post-procedure
Change in Rutherford-Becker Classification From Pre-procedure
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.
Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease
Mild claudication Moderate claudication Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia.
Measured: 24 months post-procedure
Change in Rutherford-Becker Classification From Pre-procedure
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.
Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease
Mild claudication Moderate claudication Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia.
Measured: 36 months post-procedure
Change in EQ-5D Index From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
Measured: 24 months post-procedure
Change in EQ-5D Index From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
Measured: 36 months post-procedure
Change in EQ-5D VAS From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
Measured: 24 months post procedure
Change in EQ-5D VAS From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
Measured: 36 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start18 Jun 2013
- Primary completion8 Dec 2017
- Study completion6 Oct 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Lyden, MD, Principal investigator, The Cleveland ClinicPrakash Krishnan, MD, Principal investigator, Mount Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421561
- Sponsor's protocol ID
- D035940
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2018
- Last updated
- 2 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 31567024
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Pivotal Post-Approval Study
- ClinicalTrials.gov ID
- NCT03421561
- Acronym / sponsor ID
- D035940
- Conditions
- Peripheral Artery 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
- 8 Dec 2017 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 2 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
Detailed description
The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB.
Each enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB Subjects | Experimental | Device: Stellarex 0.035" OTW Drug-coated Angioplasty BalloonThe Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. |
| PTA Subjects | Placebo comparator | Device: EverCross™ 0.035 PTA Balloon CatheterThe control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.
- Known aortic aneurysm(s) > 5 cm.
- Contraindication to dual anti-platelet therapy.
- Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
- Current participation in an investigational drug or another device study.
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 |
|---|---|---|
| Stellarex 0.035" OTW Drug-coated Angioplasty BalloonThe Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. | Device | DCB Subjects |
| EverCross™ 0.035 PTA Balloon CatheterThe control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). | Device | PTA Subjects |
Primary outcome
Number of Participants With Target Vessel Patency at 24 Months Post-procedure
Time frame: 24 months 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.
Number of Participants With 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 24 Months Post-procedure
Time frame: 24 months post-procedure
The primary safety outcome is defined as 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 (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).
42 secondary outcomes
Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 24 months post-procedure
Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 36 months post-procedure
Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 48 months post-procedure
Major Adverse Event (MAE) Rate at 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: 60 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Time frame: 24 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Time frame: 36 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Time frame: 48 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Time frame: 60 months post-procedure
Rate of Target Lesion Revascularization
Time frame: 24 months post-procedure
Rate of Target Lesion Revascularization
Time frame: 36 months post-procedure
Rate of Target Lesion Revascularization
Time frame: 48 months post-procedure
Rate of Target Lesion Revascularization
Time frame: 60 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Time frame: 24 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Time frame: 36 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Time frame: 48 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Time frame: 60 months post-procedure
Rate of Target Limb Major Amputation
Time frame: 24 months post-procedure
Rate of Target Limb Major Amputation
Time frame: 36 months post-procedure
Rate of Target Limb Major Amputation
Time frame: 48 months post-procedure
Rate of Target Limb Major Amputation
Time frame: 60 months post-procedure
Mortality Rate
Time frame: 24 months post-procedure
Mortality Rate
Time frame: 36 months post-procedure
Mortality Rate
Time frame: 48 months post-procedure
Mortality Rate
Time frame: 60 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Time frame: 24 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Time frame: 36 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Time frame: 48 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Time frame: 60 months post-procedure
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Time frame: 24 months post-procedure
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Time frame: 36 months post-procedure
Change in Ankle-brachial Index (ABI) From Pre-procedure
Time frame: 24 months post-procedure
Change in Ankle-brachial Index (ABI) From Pre-procedure
Time frame: 36 months post-procedure
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
Time frame: 24 months post-procedure
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
Time frame: 36 months post-procedure
Change in Walking Distance From Pre-procedure
Time frame: 24 months post-procedure
Change in Walking Distance From Pre-procedure
Time frame: 36 months post-procedure
Change in Rutherford-Becker Classification From Pre-procedure
Time frame: 24 months post-procedure
Change in Rutherford-Becker Classification From Pre-procedure
Time frame: 36 months post-procedure
Change in EQ-5D Index From Pre-procedure
Time frame: 24 months post-procedure
Change in EQ-5D Index From Pre-procedure
Time frame: 36 months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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.
Sean Lyden, MD principal investigator
The Cleveland Clinic
Prakash Krishnan, MD principal investigator
Mount Sinai Health System
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellarex 0.035" OTW Drug-coated Angioplasty Balloon and EverCross™ 0.035 PTA Balloon Catheter in people with Peripheral Artery Disease, run by Spectranetics Corporation at 41 sites in 2 countries.
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 0 inclusion and 23 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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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. Some participants in this study may receive a placebo. 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 2 Feb 2024). 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?
Number of Participants With Target Vessel Patency at 24 Months Post-procedure (time frame: 24 months post-procedure). 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 NCT03421561, which also lists 1 linked publication.
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 2 Feb 2024.