| Is your age between 18 yrs and 90 yrs? |
|
|
|
| Gender: Male or Female |
|
|
|
| Do you have Peripheral Arterial Disease (PAD)? |
|
|
|
| Patient is male or female, with age > 18 and ≤ 90 years at date of enrollment |
|
|
|
| Patient provides written informed consent before any study-specific investigations or procedures |
|
|
|
| Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months |
|
|
|
| Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair |
|
|
|
| Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery |
|
|
|
| Patient has PAD classified as Rutherford classification 2, 3 or 4 |
|
|
|
| Patient has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤ 0.90 (or ≤ 0.75 after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to reliably assess ABI. TBI must be <0.70. _or _(ii) Normal ABI with angiographic or ultrasound evidence of ≥ 60% diameter stenosis |
|
|
|
| Patient has single or multiple stenotic, restenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated |
|
|
|
| Single or multiple target lesions must be covered by a single stent. In the case of tandem target lesions, the gap between lesions must be ≤ 2.5 cm |
|
|
|
| Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur |
|
|
|
| Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate |
|
|
|
| Single or multiple target lesions measure ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate |
|
|
|
| Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment |
|
|
|
| Patient has at least one patent infrapopliteal vessel (< 50% stenosis) with run-off to the ankle |
|
|
|
| Patient is unable or is unwilling to comply with the procedural requirements of the study protocol or will have difficulty in complying with the requirements for attending follow-up visits |
|
|
|
| Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months |
|
|
|
| Patient has an iliac stent in target limb that has required re-intervention within 12 months prior to index |
|
|
|
| Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study |
|
|
|
| Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment |
|
|
|
| Patient has a target vessel that has been treated with bypass surgery |
|
|
|
| Patient has PAD classified as Rutherford classification 0, 1, 5 or 6 |
|
|
|
| Patient has known or suspected active systemic infection at the time of enrollment |
|
|
|
| Patient has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR (international normalized ratio) >1.8 |
|
|
|
| Patient has a stroke diagnosis within three months prior to enrollment |
|
|
|
| Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment |
|
|
|
| Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies |
|
|
|
| Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated |
|
|
|
| Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy) |
|
|
|
| Patient has received thrombolysis within 72 hours prior to the index procedure |
|
|
|