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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02568293
First Posted: October 5, 2015
Last Update Posted: February 9, 2017
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.
Collaborator:
Symic Biomedical, Inc.
Information provided by (Responsible Party):
Symic Vascular
  Purpose
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 Intervention
Peripheral Arterial Disease Other: SBCV Other: Saline

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Symic Vascular:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 66
Study Start Date: October 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
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
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

Responsible Party: Symic Vascular
ClinicalTrials.gov Identifier: NCT02568293     History of Changes
Other Study ID Numbers: TP-1601
First Submitted: October 1, 2015
First Posted: October 5, 2015
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases