ILLUMENATE Pivotal Post-Approval Study (PAS)

NCT ID: NCT03421561

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-18
• Study Completion Date: 2020-10-06

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DCB Subjects

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.

Group Type: EXPERIMENTAL

Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

Intervention Type: 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.

PTA Subjects

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.

Group Type: PLACEBO_COMPARATOR

EverCross™ 0.035 PTA Balloon Catheter

Intervention Type: DEVICE

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

Interventions

Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

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.

Intervention Type: DEVICE

EverCross™ 0.035 PTA Balloon Catheter

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Study subjects must fulfill the following clinical criteria:

1. Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery.

2. Greater than or equal to 18 years of age.

3. 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.

4. 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).

5. Life expectancy >1 year.

6. Rutherford-Becker classification of 2, 3 or 4.

Study Subjects must fulfill the following angiographic criteria:

7. De novo or restenotic lesion (except for in-stent restenotic lesion) >70% within the SFA and/or popliteal artery in a single limb.

8. 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.

9. Lesion is treatable by no more than two (2) study devices.

10. Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.

11. Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation).

12. 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.

13. 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.

Exclusion Criteria

Subject with any of the following clinical criteria should be excluded:

1. Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.

2. Known aortic aneurysm(s) > 5 cm.

3. Contraindication to dual anti-platelet therapy.

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

5. Current participation in an investigational drug or another device study.

6. History of hemorrhagic stroke within 3 months.

7. 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).

8. 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.

9. Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.

10. Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.

11. 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:

12. Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.

13. No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.

14. Known inadequate distal outflow.

15. Acute or sub-acute thrombus in the target vessel.

16. Aneurysmal target vessel.

17. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.

18. 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).

19. Presence of concentric calcification that precludes PTA pre-dilation.

20. Prior stent placement in the target vessel.

21. Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Lyden, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Prakash Krishnan, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Health System

Locations

Yuma Regional Medical Center

Yuma, Arizona, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Good Samaritan Hospital - Los Angeles

Los Angeles, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Cardiovascular Research of North Florida

Gainesville, Florida, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Coastal Vascular and Interventional

Pensacola, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, United States

St. Joseph Hospital

Fort Wayne, Indiana, United States

Central Iowa Hospital Corporation

Des Moines, Iowa, United States

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Metro Health Hospital

Wyoming, Michigan, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Mount Sinai Medical Center

New York, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Wake Heart Research

Raleigh, North Carolina, United States

Rex Hospital

Raleigh, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

OhioHealth Research Institute

Columbus, Ohio, United States

North Ohio Research LTD.

Elyria, Ohio, United States

Jobst Vascular Institute

Toledo, Ohio, United States

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States

Heritage Valley Health System

Beaver, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute, INC.

Wormleysburg, Pennsylvania, United States

Sanford Health Vascular Associates

Sioux Falls, South Dakota, United States

University Surgical Associates

Chattanooga, Tennessee, United States

Wellmont Holston Valley Medical

Kingsport, Tennessee, United States

Premier Surgical Associates

Knoxville, Tennessee, United States

Texas Health & Research Education Institution

Dallas, Texas, United States

El Paso Cardiology Associates

El Paso, Texas, United States

University of Texas Health Science Center - Houston

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

CAMC Clinical Trial Center

Charleston, West Virginia, United States

Aurora Health Care

Milwaukee, Wisconsin, United States

Medical University Graz

Graz, , Austria

Hanusch Krankenhaus Wien

Vienna, , Austria

Countries

United States; Austria

References

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.

Reference Type: DERIVED

PMID: 31567024 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

D035940

Identifier Type: -

Identifier Source: org_study_id