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XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to:
Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form.
Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient.
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
II) Lesion Characteristics (enter data for up to five lesions)
IIa) CTO Characteristics (Only required for CTO lesions)
III) Intervention Details
IV) Outcomes
V) Follow-Up
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent | The patient received one or more stents to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries in AT LEAST one of the lesions treated during the course of the procedure. | ||
| Non-Stent | The patient did not receive a stent to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries in ANY of the lesions treated during the course of the procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Target Limb Revascularization | Target Lesion or Vessel Revascularization or Surgical Revascularization/Amputation of Target Limb | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosed peripheral arterial disease who underwent endovascular intervention, and received either a stent or non-stent based treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Fernandez Vazquez, MD | Contact | 2148202928 | david.fernandezvazquez@bswhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Subhash Banerjee, MD | Baylor Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Heart Institute | Completed | Little Rock | Arkansas | 72211 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34706553 | Derived | Patel K, Liu Y, Etaee F, Patel C, Monteleone P, Patel M, Amer Alaiti M, Metzger C, Banerjee A, Minniefield N, Tejani I, Brilakis ES, Shishehbor MH, Banerjee S. Differences Between Patients With Intermittent Claudication and Critical Limb Ischemia Undergoing Endovascular Intervention: Insights From the Excellence in Peripheral Artery Disease Registry. Circ Cardiovasc Interv. 2021 Nov;14(11):e010635. doi: 10.1161/CIRCINTERVENTIONS.121.010635. Epub 2021 Oct 27. | |
| 31686573 |
| Label | URL |
|---|---|
| XLPAD Registry Website | View source |
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| Denver VAMC |
| Completed |
| Denver |
| Colorado |
| 80220 |
| United States |
| Emory University | Completed | Atlanta | Georgia | 30322 | United States |
| Loyola University Medical Center | Completed | Chicago | Illinois | 60153 | United States |
| Indiana University Health Ball Memorial Hospital | Completed | Muncie | Indiana | 47303 | United States |
| Mid West Cardiovascular Research Foundation | Completed | Davenport | Iowa | 52803 | United States |
| VA Boston Healthcare System | Completed | Boston | Massachusetts | 02301 | United States |
| Detroit Medical Center | Recruiting | Detroit | Michigan | 48201 | United States |
|
| St. Louis University Medical Center | Completed | St Louis | Missouri | 63104 | United States |
| Carolina East Health System | Completed | New Bern | North Carolina | 28560 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 38732 | United States |
|
| Harrington Heart and Vascular Institute, University Hospitals | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| Oklahoma University Health Science Center | Completed | Oklahoma City | Oklahoma | 73104 | United States |
| Integris Heart Hospital | Completed | Oklahoma City | Oklahoma | 73109 | United States |
| Albert Einstein Healthcare Network | Completed | Philadelphia | Pennsylvania | 19141 | United States |
| Wellmont CVA Heart Institute | Recruiting | Kingsport | Tennessee | 37663 | United States |
|
| Seton Heart Institute/ UT Austin | Recruiting | Austin | Texas | 78705 | United States |
|
| Cardiothoracic and Vascular Surgeons | Completed | Austin | Texas | 78756 | United States |
| Christus Sphon Hospital Corpus Christi-Shoreline | Completed | Corpus Christi | Texas | 78404 | United States |
| North Texas Veteran Affairs Medical Center | Recruiting | Dallas | Texas | 75216 | United States |
|
| Baylor Scott & White Research Institute | Recruiting | Dallas | Texas | 75226 | United States |
|
| El Paso Cardiovascular Care | Completed | El Paso | Texas | 79925 | United States |
| North Dallas Research Associates | Completed | McKinney | Texas | 75069 | United States |
| UT Health Sciences Center | Completed | San Antonio | Texas | 78229 | United States |
| Derived |
| Armstrong EJ, Jeon-Slaughter H, Kahlon RS, Niazi KA, Shammas NW, Banerjee S. Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry. J Endovasc Ther. 2020 Feb;27(1):60-65. doi: 10.1177/1526602819885652. Epub 2019 Nov 5. |
| 29923459 | Derived | Kokkinidis DG, Jeon-Slaughter H, Khalili H, Brilakis ES, Shammas NW, Banerjee S, Armstrong EJ. Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry. Vasc Med. 2018 Aug;23(4):358-364. doi: 10.1177/1358863X18775593. Epub 2018 Jun 20. |
| 28440113 | Derived | Shammas AN, Jeon-Slaughter H, Tsai S, Khalili H, Ali M, Xu H, Rodriguez G, Cawich I, Armstrong EJ, Brilakis ES, Banerjee S. Major Limb Outcomes Following Lower Extremity Endovascular Revascularization in Patients With and Without Diabetes Mellitus. J Endovasc Ther. 2017 Jun;24(3):376-382. doi: 10.1177/1526602817705135. Epub 2017 Apr 25. |
| 27832850 | Derived | Banerjee S, Jeon-Slaughter H, Tsai S, Mohammad A, Foteh M, Abu-Fadel M, Gigliotti OS, Cawich I, Rodriguez G, Kumbhani D, Addo T, Luna M, Das TS, Prasad A, Armstrong EJ, Shammas NW, Brilakis ES. Comparative Assessment of Procedure Cost and Outcomes Between Guidewire and Crossing Device Strategies to Cross Peripheral Artery Chronic Total Occlusions. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2243-2252. doi: 10.1016/j.jcin.2016.08.010. |
| 26839391 | Derived | Banerjee S, Sarode K, Mohammad A, Gigliotti O, Baig MS, Tsai S, Shammas NW, Prasad A, Abu-Fadel M, Klein A, Armstrong EJ, Jeon-Slaughter H, Brilakis ES, Bhatt DL. Femoropopliteal Artery Stent Thrombosis: Report From the Excellence in Peripheral Artery Disease Registry. Circ Cardiovasc Interv. 2016 Feb;9(2):e002730. doi: 10.1161/CIRCINTERVENTIONS.115.002730. |
| 25985785 | Derived | Banerjee S, Sarode K, Patel A, Mohammad A, Parikh R, Armstrong EJ, Tsai S, Shammas NW, Brilakis ES. Comparative Assessment of Guidewire and Microcatheter vs a Crossing Device-Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions. J Endovasc Ther. 2015 Aug;22(4):525-34. doi: 10.1177/1526602815587707. Epub 2015 May 18. |
| 25091095 | Derived | Banerjee S, Thomas R, Sarode K, Mohammad A, Sethi S, Baig MS, Gigliotti OS, Ali MI, Klein A, Abu-Fadel MS, Shammas NW, Prasad A, Brilakis ES. Crossing of infrainguinal peripheral arterial chronic total occlusion with a blunt microdissection catheter. J Invasive Cardiol. 2014 Aug;26(8):363-9. |
| 24754288 | Derived | Banerjee S, Sarode K, Das T, Hadidi O, Thomas R, Vinas A, Garg P, Mohammad A, Baig MS, Shammas NW, Brilakis ES. Endovascular treatment of infrainguinal chronic total occlusions using the TruePath device: features, handling, and 6-month outcomes. J Endovasc Ther. 2014 Apr;21(2):281-8. doi: 10.1583/13-4527R.1. |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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