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ILLUMENATE Pivotal Post-Approval Study (PAS) | Clinical Trials | Clareo Health

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ILLUMENATE Pivotal Post-Approval Study (PAS)

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

NCT03421561•Spectranetics Corporation

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

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.
+13 more criteria

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

Key Dates

Start Date

June 18, 2013

Primary Completion Date

December 8, 2017

Completion Date

October 6, 2020

Last Updated

February 2, 2024

Enrollment

300

ACTUAL participants

Conditions

Peripheral Artery Disease

Interventions

Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

DEVICE

EverCross™ 0.035 PTA Balloon Catheter

DEVICE

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Peripheral Artery Disease

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RECRUITINGEARLY_PHASE1

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

NCT06212271

Peripheral Artery Disease

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RECRUITING

Vascular Lab Resource (VLR) Biorepository

NCT05628948

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ILLUMENATE Pivotal Post-Approval Study (PAS)

Inclusion Criteria

Exclusion Criteria

Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Vascular Lab Resource (VLR) Biorepository

The COCOA-PAD II Trial

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)