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

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SBCV
Saline
Sponsored by
Symic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Prince Alfred Hospital
  • Royal North Shore Hospital
  • Gold Coast University Hospital
  • Flinders Medical Center
  • Austin Health
  • The Alfred Hospital
  • Sir Charles Gairdner Hospital
  • Auckland City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SBCV

Control

Arm Description

SBCV is administered to the site immediately post balloon dilation.

Saline is used as a control and is delivered immediately post balloon dilation.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events
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
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.

Secondary Outcome Measures

Full Information

First Posted
October 1, 2015
Last Updated
February 8, 2017
Sponsor
Symic Vascular
Collaborators
Symic Biomedical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02568293
Brief Title
Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
Acronym
SHIELD
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Symic Vascular
Collaborators
Symic Biomedical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBCV
Arm Type
Experimental
Arm Description
SBCV is administered to the site immediately post balloon dilation.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Saline is used as a control and is delivered immediately post balloon dilation.
Intervention Type
Other
Intervention Name(s)
SBCV
Intervention Description
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Saline is used as a control.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Description
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
Time Frame
through 24 weeks
Title
Late Lumen Loss
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Melbourne
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Flinders Medical Center
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5043
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis

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