ILLUMENATE Pivotal Post-Approval Study (PAS)

NCT03421561 | Completed Results FDA Device

• 1 other identifier: D035940
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 41

Brief 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 post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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)

  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)

  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)

  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)

  60 months post-procedure

• Rate of Clinically-driven Target Lesion Revascularization

  24 months post-procedure

Study Arms (2)

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.

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.

Device: EverCross™ 0.035 PTA Balloon Catheter

Interventions

Stellarex 0.035" OTW Drug-coated Angioplasty Balloon DEVICE

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.

DCB Subjects

EverCross™ 0.035 PTA Balloon Catheter DEVICE

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

PTA Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study subjects must fulfill the following clinical criteria:
• Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery.
• Greater than or equal to 18 years of age.
• Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows.
• Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
• Life expectancy \>1 year.
• Rutherford-Becker classification of 2, 3 or 4.
• Study Subjects must fulfill the following angiographic criteria:
• De novo or restenotic lesion (except for in-stent restenotic lesion) \>70% within the SFA and/or popliteal artery in a single limb.
• Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm.
• Lesion is treatable by no more than two (2) study devices.
• Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.
• Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation).
• Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis \<30% without death or major vascular complication.
• Target limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior magnetic resonance (MR) angiography or computed tomography (CT) angiography (within 45 days prior to index procedure). NOTE: treatment of outflow disease is NOT permitted.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (41)

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

Good Samaritan Hospital - Los Angeles

Los Angeles, California, 90017, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Cardiovascular Research of North Florida

Gainesville, Florida, 32605, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32504, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, 60181, United States

Location

St. Joseph Hospital

Fort Wayne, Indiana, 46802, United States

Location

Central Iowa Hospital Corporation

Des Moines, Iowa, 50309, United States

Location

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Metro Health Hospital

Wyoming, Michigan, 15146, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Wake Heart Research

Raleigh, North Carolina, 19010, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

North Ohio Research LTD.

Elyria, Ohio, 44035, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Heritage Valley Health System

Beaver, Pennsylvania, 15009, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Pinnacle Health Cardiovascular Institute, INC.

Wormleysburg, Pennsylvania, 17043, United States

Location

Sanford Health Vascular Associates

Sioux Falls, South Dakota, 57117, United States

Location

University Surgical Associates

Chattanooga, Tennessee, 37403, United States

Location

Wellmont Holston Valley Medical

Kingsport, Tennessee, 37660, United States

Location

Premier Surgical Associates

Knoxville, Tennessee, 37909, United States

Location

Texas Health & Research Education Institution

Dallas, Texas, 75231, United States

Location

El Paso Cardiology Associates

El Paso, Texas, 79902, United States

Location

University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

CAMC Clinical Trial Center

Charleston, West Virginia, 25304, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

Medical University Graz

Graz, Austria

Location

Hanusch Krankenhaus Wien

Vienna, Austria

Location

Related Publications (1)

• 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.

  PMID: 31567024 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Nicolas Aguirre
• Organization: Philips

nicolas.aguirre@philips.com

612-297-6655

Study Officials

• Sean Lyden, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Prakash Krishnan, MD

  Mount Sinai Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 5, 2018
• Study Start: June 18, 2013
• Primary Completion: December 8, 2017
• Study Completion: October 6, 2020
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2024-01

Locations

AU (2); US (39)