Peripheral Arterial Disease Clinical Trial
— SHIELDOfficial 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
Verified date | February 2017 |
Source | Symic Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
Status | Active, not recruiting |
Enrollment | 66 |
Est. completion date | October 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Flinders Medical Center | Adelaide | South Australia |
Australia | Austin Health | Heidelberg | Victoria |
Australia | Royal Prince Alfred Hospital | Melbourne | New South Wales |
Australia | The Alfred Hospital | Melbourne | Victoria |
Australia | Sir Charles Gairdner Hospital | Perth | Western Australia |
Australia | Gold Coast University Hospital | Southport | Queensland |
Australia | Royal North Shore Hospital | Sydney | New South Wales |
New Zealand | Auckland City Hospital | Auckland |
Lead Sponsor | Collaborator |
---|---|
Symic Vascular | Symic Biomedical, Inc. |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
through 24 weeks | |
Primary | 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. | 24 weeks |
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