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|
| General |
| Study Status |
Progress Adequate |
| Application Number |
P110023 / PAS001 |
| Date Current Protocol Accepted |
11/23/2016
|
| Study Name |
OSB Lead-Durability II PAS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Design Description |
The PAS is a prospective, multi‐center, non‐randomized, single arm study with sequential enrollment of all qualified subjects undergoing treatment of atherosclerotic lesions in the native superficial femoral artery or the superficial femoral and proximal popliteal arteries. All eligible subjects who provide informed consent will undergo PTA and stenting using the EverFlex device. Follow‐up will take place at pre‐ discharge, 30 days, 1 year, 2 years and 3 years.
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| Study Population Description |
Adult patients with lesions no greater than 180 mm in length in the native superficial femoral artery or the superficial femoral and proximal popliteal arteries, who do not meet any of the exclusion criteria for this device.
|
| Sample Size |
The sample size of 108 is driven by the need for the above noted precision confidence interval for stent fracture rate. This sample size will ensure precision of the stent fracture rate at 1 year with a 95% confidence interval upper bound of 6.6%, assuming a proportion of 1 year fracture rate of 3.0%, and a 10% attrition at 1 year. Also, assuming that the true 36 month composite primary endpoint rate is 55% (with a performance goal of greater than 35%) and 30% attrition at 36 months, the resulting 108 evaluable subjects are greater than the 89 required to power the primary endpoint.
Twenty (20) to 30 sites will be used in the study.
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| Data Collection |
Primary endpoints
A composite endpoint defined as freedom from acute death, freedom from 36‐month amputation, and freedom from 36‐month clinically‐
driven target lesion revascularization
Secondary endpoints
Freedom from stent fracture at 1, 2, and 3 years
Freedom from 36‐month amputation at 1, 2, and 3 years
Freedom from 36‐month clinically driven target lesion revascularization at 1, 2, and 3 yrs
Freedom from acute death (within 30 days of the procedure)
Device success ¿ ability to employ the device as intended
Improvement in Rutherford clinical category at one year
Improvement in ankle‐brachial index at one year
Walking improvement at one year
Adverse events, including all cause mortality
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| Follow-up Visits and Length of Follow-up |
Follow‐up visits will occur pre‐discharge, at one month, at one year, and annually thereafter, up to three years.
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