Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes

Patients undergoing an endovascular intervention receiving either stents or percutaneous transluminal angioplasty (PTA) to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries will be entered into this registry. Patients undergoing treatment of the external or common iliac arteries are not admissible to the registry, unless these arteries were treated in addition to one of the five aforementioned arteries. The registry will collect data in the form of patient background information, procedural data, and follow-up data from the patient's medical records. Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The data will be entered into a software, REDCAP, that automatically provides data quality verification and processing.

Specifically, the data fields collected by the registry will be:

I) Background Information

1. Site, attending operator, and month-year of procedure

2. Patient height, weight, age, race, and sex

3. Rutherford claudication category, left and right ankle brachial index, ambulatory status, claudication free distance

4. Risk factors such as diabetes, hypertension, hyperlipidemia, and prior history of lower extremity percutaneous intervention

5. Patient comorbidities such as coronary artery disease, congestive heart failure, prior myocardial infarction, stroke, transient ischemic attack, chronic kidney disease, and other.

II) Lesion Characteristics (enter data for up to five lesions)

1. Access site relative to target limb, sheath size, target limb (left or right)

2. Target vessel: superficial femoral artery, popliteal artery, peroneal artery, anterior tibial artery, or posterior tibial artery

3. Which, if any, Iliac arteries were treated during procedure

4. Target lesion location (ostial, proximal, medial, distal), estimated vessel diameter, estimated vessel length

5. Lesion characteristics (heavily calcified, diffuse, thrombus, chronic total occlusion (CTO), in-stent restenosis, restenosis post balloon angioplasty, profunda femoris disease)

6. Planned revascularization strategy: stent or non-stent based

IIa) CTO Characteristics (Only required for CTO lesions)

1. Type of proximal and distal stumps, sidebranches present, collateral filling of distal vessel, tortuosity, prior attempt to cross CTO

2. Antegrade or retrograde crossing strategy, crossing technique, number of attempts

3. Crossing devices used, microcatheters used, sub-intimal re-entry devices used (if any), embolic protection device used

III) Intervention Details

1. Atherectomy device used (Cutting Balloon, TurboHawk, SilverHawk, Rotablator, Laser)

2. Pre and post-dilation balloon information (type, length, width, average atmospheric pressure, number of inflations)

3. Stent information (indication for stents, length, width, maximum pressure, overlapping with previous stents)

4. Aspiration/Thrombectomy used, thrombolytic therapy used

5. Percent change in stenosis and TIMI flows (before and after)

IV) Outcomes

1. Technical success (<30% residual stenosis), procedural success (<30% residual stenosis without complications), and case comments

2. Anti-coagulation used, medical therapy (plavix, aspirin, lipid lowering therapy, angiotensin receptor blocker, beta blocker, cilostazol, trental, insulin, oral hypoglycemics)

3. Duration of procedure, fluoroscopy (amount used, type, and time)

4. Any procedural complications

V) Follow-Up

1. Month and year of follow-up

2. Rutherford category, left and right ankle brachial index, claudication-free distance, ambulatory status, change in claudication (improved, same, or worsened)

3. Duplex ultrasound performed

4. Adverse events experienced (death, myocardial infarction, stroke, stent thrombosis, stent fracture, angiography, repeat endovascular intervention, surgical revascularization, amputation in target or non-target limb)

Follow-up data is recorded from clinical visits six and twelve months after the procedure. If the patient undergoes a repeat intervention on the target limb, a new record is created for the procedure.