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Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon (ILLUMENATE)

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ClinicalTrials.gov Identifier: NCT01858428
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : January 17, 2018
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation

Study Description
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Brief Summary:
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter Device: EverCross Percutaneous Transluminal Balloon Catheter Not Applicable

Detailed Description:
The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: ILLUMENATE Pivotal: 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
Actual Study Start Date : June 18, 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bare PTA
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
 Device: EverCross Percutaneous Transluminal Balloon Catheter
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
Experimental: Drug-Coated PTA
The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
 Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.


Outcome Measures
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Primary Outcome Measures :
  1. Patency at 12 Month Post-procedure [ Time Frame: 12 months ]
    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.

  2. Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization [ Time Frame: 30 Days and 12 months ]
    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 12 months post-procedure.


Secondary Outcome Measures :
  1. Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ]
    Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

  2. Rate of Vascular Access and Bleeding Complications [ Time Frame: in-hospital and 1, 6, 12 and 24 months ]
    Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.

  3. Rate of Clinically-driven Target Lesion Revascularization [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
  4. Rate of Target Lesion Revascularization [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
  5. Rate of Target Limb Major Amputation [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ]
  6. Mortality Rate [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
  7. Rate of Occurrence of Arterial Thrombosis of the Treated Segment [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ]
  8. Patency Rate and Freedom From Clinically-driven TLR [ Time Frame: 6, 24 and 36 months ]
    Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months

  9. Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% [ Time Frame: procedure, Day 0 ]
    Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.

  10. Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% [ Time Frame: procedure, Day 0 ]
    Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.

  11. Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure [ Time Frame: procedure, Day 0 ]
    Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.

  12. Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure [ Time Frame: procedure, Day 0 ]
    Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.

  13. Change in Ankle-brachial Index (ABI) From Pre-procedure [ Time Frame: 6, 12, 24 and 36 months ]
    Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Exclusion Criteria:

  • Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858428


Locations
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Sponsors and Collaborators
Spectranetics Corporation
Investigators
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Principal Investigator: Prakash Krishnan, MD Mt. Sinai Medical Center
Principal Investigator: Sean Lyden, MD The Cleveland Clinic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01858428    
Other Study ID Numbers: TP-1397
First Posted: May 21, 2013    Key Record Dates
Results First Posted: January 17, 2018
Last Update Posted: August 24, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
 Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action