Clinical trial NCT03421561: ILLUMENATE Pivotal Post-Approval Study (PAS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria - From ILLUMENATE Pivotal IDE population TP-1397E

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.

Primary outcomes:
measure: Number of Participants With Target Vessel Patency at 24 Months Post-procedure
timeFrame: 24 months post-procedure
measure: 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
timeFrame: 24 months post-procedure
Secondary outcomes:
measure: 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)
timeFrame: 24 months post-procedure
measure: 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)
timeFrame: 36 months post-procedure
measure: 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)
timeFrame: 48 months post-procedure
measure: 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)
timeFrame: 60 months post-procedure
measure: Rate of Clinically-driven Target Lesion Revascularization
timeFrame: 24 months post-procedure
measure: Rate of Clinically-driven Target Lesion Revascularization
timeFrame: 36 months post-procedure
measure: Rate of Clinically-driven Target Lesion Revascularization
timeFrame: 48 months post-procedure
measure: Rate of Clinically-driven Target Lesion Revascularization
timeFrame: 60 months post-procedure
measure: Rate of Target Lesion Revascularization
timeFrame: 24 months post-procedure
measure: Rate of Target Lesion Revascularization
timeFrame: 36 months post-procedure
measure: Rate of Target Lesion Revascularization
timeFrame: 48 months post-procedure
measure: Rate of Target Lesion Revascularization
timeFrame: 60 months post-procedure
measure: Rate of Clinically-driven Target Vessel Revascularization
timeFrame: 24 months post-procedure
measure: Rate of Clinically-driven Target Vessel Revascularization
timeFrame: 36 months post-procedure
measure: Rate of Clinically-driven Target Vessel Revascularization
timeFrame: 48 months post-procedure
measure: Rate of Clinically-driven Target Vessel Revascularization
timeFrame: 60 months post-procedure
measure: Rate of Target Limb Major Amputation
timeFrame: 24 months post-procedure
measure: Rate of Target Limb Major Amputation
timeFrame: 36 months post-procedure
measure: Rate of Target Limb Major Amputation
timeFrame: 48 months post-procedure
measure: Rate of Target Limb Major Amputation
timeFrame: 60 months post-procedure
measure: Mortality Rate
timeFrame: 24 months post-procedure
measure: Mortality Rate
timeFrame: 36 months post-procedure
measure: Mortality Rate
timeFrame: 48 months post-procedure
measure: Mortality Rate
timeFrame: 60 months post-procedure
measure: Rate of Occurrence of Arterial Thrombosis of the Treated Segment
timeFrame: 24 months post-procedure
measure: Rate of Occurrence of Arterial Thrombosis of the Treated Segment
timeFrame: 36 months post-procedure
measure: Rate of Occurrence of Arterial Thrombosis of the Treated Segment
timeFrame: 48 months post-procedure
measure: Rate of Occurrence of Arterial Thrombosis of the Treated Segment
timeFrame: 60 months post-procedure
measure: Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
timeFrame: 24 months post-procedure
measure: Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
timeFrame: 36 months post-procedure
measure: Change in Ankle-brachial Index (ABI) From Pre-procedure
timeFrame: 24 months post-procedure
measure: Change in Ankle-brachial Index (ABI) From Pre-procedure
timeFrame: 36 months post-procedure
measure: Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
timeFrame: 24 months post-procedure
measure: Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
timeFrame: 36 months post-procedure
measure: Change in Walking Distance From Pre-procedure
timeFrame: 24 months post-procedure
measure: Change in Walking Distance From Pre-procedure
timeFrame: 36 months post-procedure
measure: Change in Rutherford-Becker Classification From Pre-procedure
timeFrame: 24 months post-procedure
measure: Change in Rutherford-Becker Classification From Pre-procedure
timeFrame: 36 months post-procedure
measure: Change in EQ-5D Index From Pre-procedure
timeFrame: 24 months post-procedure
measure: Change in EQ-5D Index From Pre-procedure
timeFrame: 36 months post-procedure
measure: Change in EQ-5D VAS From Pre-procedure
timeFrame: 24 months post procedure
measure: Change in EQ-5D VAS From Pre-procedure
timeFrame: 36 month post procedure
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital - Los Angeles
state: California
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: Cardiovascular Research of North Florida
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Oakbrook Terrace
country: United States
facility: Advocate Health and Hospitals Corporation
state: Illinois
city: Fort Wayne
country: United States
facility: St. Joseph Hospital
state: Indiana
city: Des Moines
country: United States
facility: Central Iowa Hospital Corporation
state: Iowa
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research LTD.
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Beaver
country: United States
facility: Heritage Valley Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute, INC.
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Health Vascular Associates
state: South Dakota
city: Chattanooga
country: United States
facility: University Surgical Associates
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical
state: Tennessee
city: Knoxville
country: United States
facility: Premier Surgical Associates
state: Tennessee
city: Dallas
country: United States
facility: Texas Health & Research Education Institution
state: Texas
city: El Paso
country: United States
facility: El Paso Cardiology Associates
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center - Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Charleston
country: United States
facility: CAMC Clinical Trial Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Graz
country: Austria
facility: Medical University Graz
city: Vienna
country: Austria
facility: Hanusch Krankenhaus Wien
Study officials:
affiliation: The Cleveland Clinic
name: Sean Lyden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Health System
name: Prakash Krishnan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.