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Trial record 28 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03175744
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : April 18, 2019
Information provided by (Responsible Party):
Spectranetics Corporation

Brief Summary:
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Device: Stellarex DCB Device: PTA Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries - ILLUMENATE BTK
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Stellarex DCB
Spectranetics Stellarex Drug Coated Balloon
Device: Stellarex DCB
Intervention with the Stellarex DCB

Active Comparator: PTA Catheter
Standard Uncoated Balloon Angioplasty Catheter
Device: PTA Catheter
Intervention with an uncoated Standard PTA

Primary Outcome Measures :
  1. Freedom from Major Adverse Limb Event (MALE) [ Time Frame: 30 days ]
    Composite of major amputation or major reintervention on a per patient basis

  2. Freedom from Perioperative Death (POD) [ Time Frame: 30 days ]
    Death on a per patient basis

  3. Patency [ Time Frame: 6 months ]
    Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

  4. Limb Salvage [ Time Frame: 6 months ]
    Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

Secondary Outcome Measures :
  1. Clinically-driven target lesion revascularization [ Time Frame: 6 months ]
    Rate of clinically-driven target lesion revascularization

  2. Major adverse event rates [ Time Frame: 6 months ]
    Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention

  3. Patency rate [ Time Frame: 6 months ]
    Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Rutherford Clinical Category 4-5
  • Life expectancy > 1 year
  • Significant stenosis ≥70%
  • Patent inflow artery
  • Target vessel(s) diameter between 2 and 4 mm
  • Target vessel(s) reconstitute(s) at the ankle

Exclusion Criteria:

  • Pregnant or planning to become pregnant
  • History of stroke within 3 months
  • Planned major amputation
  • eGFR <30
  • Acute limb ischemia
  • Prior stent placement in target lesion

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 identifier (NCT number): NCT03175744

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Contact: Janiece Rutherford 1-763-955-1143

  Show 30 Study Locations
Sponsors and Collaborators
Spectranetics Corporation
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Principal Investigator: William Gray, MD Lankenau Heart Institute
Principal Investigator: Mahmood K Razavi, MD Vascular and Interventional Specialists of Orange
Principal Investigator: Dierk Scheinert, MD University of Leipzig

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Responsible Party: Spectranetics Corporation Identifier: NCT03175744     History of Changes
Other Study ID Numbers: D032150
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Pathologic Processes