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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Spectranetics Corporation
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT01858428
First received: May 8, 2013
Last updated: March 7, 2015
Last verified: March 2015
  Purpose

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 Intervention
Peripheral Arterial Disease
Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Device: EverCross Percutaneous Transluminal Balloon Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Spectranetics Corporation:

Primary Outcome Measures:
  • Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patency at 12 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.

  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Major adverse event (MAE) rate [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
    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).

  • Rate of vascular access and bleeding complications [ Time Frame: in-hospital and 1, 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
    Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.

  • Rate of clinically-driven target lesion revascularization [ Time Frame: 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
  • Rate of target lesion revascularization [ Time Frame: 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
  • Rate of target limb major amputation [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
  • Mortality rate [ Time Frame: 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
  • Rate of occurrence of arterial thrombosis of the treated segment [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
  • Patency rate and freedom from clinically-driven TLR [ Time Frame: 6, 24 and 36 months ] [ Designated as safety issue: Yes ]
    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

  • Lesion success [ Time Frame: procedure ] [ Designated as safety issue: Yes ]
    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.

  • Technical success [ Time Frame: procedure ] [ Designated as safety issue: Yes ]
    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.

  • Clinical success [ Time Frame: procedure ] [ Designated as safety issue: Yes ]
    Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.

  • Procedural success [ Time Frame: procedure ] [ Designated as safety issue: Yes ]
    Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.

  • Change in ankle-brachial index (ABI) from pre-procedure [ Time Frame: 6, 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
  • Change in walking impairment questionnaire (WIQ) from pre-procedure [ Time Frame: 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
  • Change in walking distance from pre-procedure [ Time Frame: 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
  • Change in Rutherford-Becker classification of chronic limb ischemia from pre-procedure [ Time Frame: 6, 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
  • Change in EQ-5D from pre-procedure [ Time Frame: 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    The EQ-5D questionnaire will be completed to assess subject-reported quality of life


Estimated Enrollment: 360
Study Start Date: June 2013
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858428

  Show 45 Study Locations
Sponsors and Collaborators
Spectranetics Corporation
Investigators
Principal Investigator: Prakash Krishnan, MD Mt. Sinai Medical Center
Principal Investigator: Sean Lyden, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01858428     History of Changes
Other Study ID Numbers: TP-1397
Study First Received: May 8, 2013
Last Updated: March 7, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on May 21, 2015