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Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis (SHIELD)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568293
Recruitment Status : Unknown
Verified February 2017 by Symic Vascular.
Recruitment status was:  Active, not recruiting
First Posted : October 5, 2015
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Symic Biomedical, Inc.
Information provided by (Responsible Party):
Symic Vascular

Tracking Information
First Submitted Date  ICMJE October 1, 2015
First Posted Date  ICMJE October 5, 2015
Last Update Posted Date February 9, 2017
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2015)
  • Incidence of treatment-emergent adverse events [ Time Frame: through 24 weeks ]
    The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment:
    • Index limb amputation (above or below the ankle)
    • Index limb re-intervention
    • Index-limb-related death
  • Late Lumen Loss [ Time Frame: 24 weeks ]
    LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • Safety [ Time Frame: through 24 weeks ]
    The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment:
    • Index limb amputation (above or below the ankle)
    • Index limb re-intervention
    • Index-limb-related death
  • Late Lumen Loss [ Time Frame: 24 weeks ]
    LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
Official Title  ICMJE A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery
Brief Summary The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
Detailed Description This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • Other: SBCV
    SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
  • Other: Saline
    Saline is used as a control.
Study Arms  ICMJE
  • Experimental: SBCV
    SBCV is administered to the site immediately post balloon dilation.
    Intervention: Other: SBCV
  • Placebo Comparator: Control
    Saline is used as a control and is delivered immediately post balloon dilation.
    Intervention: Other: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 2, 2015)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s)
  • Rutherford Clinical Category 1-4 (claudication or critical limb ischemia)
  • Lesions are ≥70% stenosis by visual estimate
  • A patent inflow artery free from significant lesion
  • At least one patent native outflow artery to the ankle

Exclusion Criteria:

  • History of haemorrhagic stroke within 3 months of screening
  • History of myocardial infarction, thrombolysis or angina within 2 weeks of screening
  • Renal failure or chronic kidney disease
  • Severe calcification that renders the lesion undilatable
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02568293
Other Study ID Numbers  ICMJE TP-1601
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Symic Vascular
Study Sponsor  ICMJE Symic Vascular
Collaborators  ICMJE Symic Biomedical, Inc.
Investigators  ICMJE Not Provided
PRS Account Symic Vascular
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP