Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.

Rutherford/Becker Categories:

0 - Asymptomatic, no hemodynamically significant occlusive disease.

1. - Mild claudication.
2. - Moderate claudication.
3. - Severe claudication.
4. - Ischemic rest pain.
5. - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.
6. - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.

In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.

In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.

Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.

Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)

Stent fractures determined by fluoroscopy .

Stent fracture and Involuntary stent migration are types of device System Failure.

Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.

Stent fracture and Involuntary stent migration are types of device System Failure.

Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

Lesion length is site reported

Percent diameter stenosis is site reported.

Core laboratory reported

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

The number of patients analyzed is based on the data available.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

The number of patients analyzed is based on the data available.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

The number of patients analyzed is based on the data available.

Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.

Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.

Rutherford/Becker Categories:

0 - Asymptomatic, no hemodynamically significant occlusive disease.

1. - Mild claudication.
2. - Moderate claudication.
3. - Severe claudication.
4. - Ischemic rest pain.
5. - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.
6. - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.

The number of patients analyzed is based on the data available.

In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.

If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.

The number of patients analyzed is based on the data available.

In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.

If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.

The number of patients analyzed is based on the data available.

Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

The number of patients analyzed is based on the data available.

Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.

Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)

The number of patients analyzed is based on the data available.

Stent fractures determined by fluoroscopy .

The number of patients analyzed is based on the data available.

Stent fracture and Involuntary stent migration are types of device System Failure.

Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.

The number of patients analyzed is based on the data available.

Stent fracture and Involuntary stent migration are types of device System Failure.

Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.

The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

The number of patients analyzed is based on the data available.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

The number of patients analyzed is based on the data available.

Death:

All-cause mortality.

Amputation:

All-cause limb amputation.

After the perioperative period, an episode of internal or external bleeding that causes death, hospitalization, and permanent injury or necessitates transfusion of >20 cc/kg of body weight packed red blood cells in a 24-h period.

Death:

All-cause mortality.