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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: SBCV Other: Saline Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arms and Interventions
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Arm Intervention/treatment
Experimental: SBCV
SBCV is administered to the site immediately post balloon dilation.
 Other: SBCV
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
Placebo Comparator: Control
Saline is used as a control and is delivered immediately post balloon dilation.
 Other: Saline
Saline is used as a control.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT02568293


Locations
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Australia, New South Wales
Royal Prince Alfred Hospital
Melbourne, New South Wales, Australia, 2050
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Australia, Queensland
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Australia, South Australia
Flinders Medical Center
Adelaide, South Australia, Australia, 5043
Australia, Victoria
Austin Health
Heidelberg, Victoria, Australia, 3084
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Sponsors and Collaborators
Symic Vascular
Symic Biomedical, Inc.
More Information
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Responsible Party: Symic Vascular
ClinicalTrials.gov Identifier: NCT02568293    
Other Study ID Numbers: TP-1601
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases