Peripheral Arterial DiseaseSHIELDNCT02568293
Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
A study testing SBCV and Saline in people with Peripheral Arterial Disease, run by Symic Vascular at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- SBCV and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia7 sites
Flinders Medical Center
Adelaide, South Australia, 5043
Austin Health
Heidelberg, Victoria, 3084
Royal Prince Alfred Hospital
Melbourne, New South Wales, 2050
The Alfred Hospital
Melbourne, Victoria, 3181
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Gold Coast University Hospital
Southport, Queensland, 4215
Royal North Shore Hospital
Sydney, New South Wales, 2065
About this study
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
The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- SBCV, Saline
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBCVOther
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
SalineOther
Saline is used as a control.
| Study group | Role | What they receive |
|---|---|---|
| SBCV | Experimental | SBCV is administered to the site immediately post balloon dilation. Receives: Other: SBCV |
| Control | Placebo comparator | Saline is used as a control and is delivered immediately post balloon dilation. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symic Biomedical, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568293
- Sponsor's protocol ID
- TP-1601
- Acronym
- SHIELD
- Status last verified
- Feb 2017
- First submitted
- 1 Oct 2015
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02568293
- Acronym / sponsor ID
- SHIELD / TP-1601
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Symic VascularIndustry (pharma, biotech, devices)
- Collaborators
- Symic Biomedical, Inc.
- Study start
- Oct 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBCV | Experimental | Other: SBCVSBCV is administered to the site immediately post balloon dilation. |
| Control | Placebo comparator | Other: SalineSaline is used as a control and is delivered immediately post balloon dilation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBCVSBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall. | Other | SBCV |
| SalineSaline is used as a control. | Other | Control |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBCV and Saline in people with Peripheral Arterial Disease, run by Symic Vascular at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: through 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.