First in Human Early Feasibility study of BD(TM) Sirolimus Drug Coated Balloon Catheter for Treatment of Femoropopliteal Arteries
Not Applicable
- Conditions
- Peripheral Artery DiseaseFemoropopliteal lesionsSuperficial Femoral Artery lesionsCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12622000071729
- Lead Sponsor
- Becton, Dickinson and Company (BD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Greater than or equal to 18 years of age
Rutherford Clinical Category 2-4
Lesion greater than or equal to 70% stenosis by visual estimate
Lesion Length greater than or equal to 3 cm and less than or equal to 17 cm
Target reference vessel diameter of 5-6 mm and able to be treated with available device size matrix
Exclusion Criteria
Less than or equal to 90 years of age
Life expectancy of less than 2 years
Participant has acute limb ischemia
Severe Calcification as defined as PARC scoring system
Participant is currently participating in an investigational drug or device study, or previously enrolled in a trial within the last 30 days prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 Months [6 months post interventional angioplasty with the BD(TM) Sirolimus Drug Coated Balloon.]
- Secondary Outcome Measures
Name Time Method A Safety Composite comprised of the following data points will be collected through patient medical records and patient reporting at follow up visits.<br>Composite of freedom from device and procedure related death. Freedom from major target limb amputation (above the ankle). Freedom from all-cause MACE. Freedom from all-cause death through.<br>[30-days post angioplasty: Composite of freedom from device and procedure related death through <br>6, 12, 24 months post angioplasty: Freedom from major target limb amputation (above the ankle). Freedom from all-cause MACE. Freedom from all-cause death.]