---
title: ILLUMENATE Pivotal Post-Approval Study (PAS)
nct_id: NCT03421561
overall_status: COMPLETED
phase: NA
sponsor: Spectranetics Corporation
study_type: INTERVENTIONAL
primary_condition: Peripheral Artery Disease
countries: United States, Austria
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03421561.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03421561"
ct_last_update_post_date: 2024-02-02
last_seen_at: "2026-05-12T06:16:55.625Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT03421561](https://clinicaltrials.gov/study/NCT03421561)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 300
- **Lead Sponsor:** Spectranetics Corporation
- **Conditions:** Peripheral Artery Disease
- **Start Date:** 2013-06-18
- **Completion Date:** 2020-10-06
- **CT.gov Last Update:** 2024-02-02

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **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.

## 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.
- **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).

## Primary Outcomes

- **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).

## 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)_
- **Change in EQ-5D VAS From Pre-procedure** _(time frame: 24 months post procedure)_
- **Change in EQ-5D VAS From Pre-procedure** _(time frame: 36 month post procedure)_

## Locations (41)

- 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

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `locations.jobst vascular institute|toledo|ohio|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.yuma regional medical center|yuma|arizona|united states` — added _(2026-05-12)_
- `locations.mission cardiovascular research institute|fremont|california|united states` — added _(2026-05-12)_
- `locations.good samaritan hospital - los angeles|los angeles|california|united states` — added _(2026-05-12)_
- `locations.medical center of the rockies|loveland|colorado|united states` — added _(2026-05-12)_
- `locations.yale university school of medicine|new haven|connecticut|united states` — added _(2026-05-12)_
- `locations.cardiovascular research of north florida|gainesville|florida|united states` — added _(2026-05-12)_
- `locations.baptist cardiac and vascular institute|miami|florida|united states` — added _(2026-05-12)_
- `locations.coastal vascular and interventional|pensacola|florida|united states` — added _(2026-05-12)_
- `locations.emory university hospital|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.northside hospital|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.advocate health and hospitals corporation|oakbrook terrace|illinois|united states` — added _(2026-05-12)_
- `locations.st. joseph hospital|fort wayne|indiana|united states` — added _(2026-05-12)_
- `locations.central iowa hospital corporation|des moines|iowa|united states` — added _(2026-05-12)_
- `locations.cardiac & vascular research center of northern michigan|petoskey|michigan|united states` — added _(2026-05-12)_
- `locations.metro health hospital|wyoming|michigan|united states` — added _(2026-05-12)_
- `locations.jackson heart clinic|jackson|mississippi|united states` — added _(2026-05-12)_
- `locations.deborah heart and lung center|browns mills|new jersey|united states` — added _(2026-05-12)_
- `locations.mount sinai medical center|new york|new york|united states` — added _(2026-05-12)_
- `locations.mission hospital|asheville|north carolina|united states` — added _(2026-05-12)_
- `locations.wake heart research|raleigh|north carolina|united states` — added _(2026-05-12)_
- `locations.rex hospital|raleigh|north carolina|united states` — added _(2026-05-12)_
- `locations.cleveland clinic foundation|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.ohiohealth research institute|columbus|ohio|united states` — added _(2026-05-12)_
- `locations.north ohio research ltd.|elyria|ohio|united states` — added _(2026-05-12)_
- `locations.oklahoma foundation for cardiovascular research|oklahoma city|oklahoma|united states` — added _(2026-05-12)_
- `locations.heritage valley health system|beaver|pennsylvania|united states` — added _(2026-05-12)_
- `locations.university of pittsburgh medical center|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_
- `locations.pinnacle health cardiovascular institute, inc.|wormleysburg|pennsylvania|united states` — added _(2026-05-12)_
- `locations.sanford health vascular associates|sioux falls|south dakota|united states` — added _(2026-05-12)_
- `locations.university surgical associates|chattanooga|tennessee|united states` — added _(2026-05-12)_
- `locations.wellmont holston valley medical|kingsport|tennessee|united states` — added _(2026-05-12)_
- `locations.premier surgical associates|knoxville|tennessee|united states` — added _(2026-05-12)_
- `locations.texas health & research education institution|dallas|texas|united states` — added _(2026-05-12)_
- `locations.el paso cardiology associates|el paso|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03421561.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03421561*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*