Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes

NCT01904851 | Recruiting DMC

• 1 other identifier: STU 052012-093
• Study Type: observational
• Target: 14,000
• Locations: 1 country
• Sites: 24

Brief Summary

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:

1. 1.Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint)
2. 2.Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint)
3. 3.Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint)

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Stents; Registry; Angioplasty; Endovascular Procedures

Outcome Measures

Primary Outcomes (1)

• Target Limb Revascularization

  Target Lesion or Vessel Revascularization or Surgical Revascularization/Amputation of Target Limb

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed peripheral arterial disease who underwent endovascular intervention, and received either a stent or non-stent based treatment.

You may qualify if:

• Underwent Endovascular Intervention
• Treated Iliac, Common or Superficial Femoral, Popliteal, Peroneal, Anterior Tibial, or Posterior Tibial Arteries

You may not qualify if:

• Surgical Bypass

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (24)

Arkansas Heart Institute

Little Rock, Arkansas, 72211, United States

COMPLETED

Denver VAMC

Denver, Colorado, 80220, United States

COMPLETED

Emory University

Atlanta, Georgia, 30322, United States

COMPLETED

Loyola University Medical Center

Chicago, Illinois, 60153, United States

COMPLETED

Indiana University Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

COMPLETED

Mid West Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

COMPLETED

VA Boston Healthcare System

Boston, Massachusetts, 02301, United States

COMPLETED

Detroit Medical Center

Detroit, Michigan, 48201, United States

RECRUITING

St. Louis University Medical Center

St Louis, Missouri, 63104, United States

COMPLETED

Carolina East Health System

New Bern, North Carolina, 28560, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 38732, United States

RECRUITING

Harrington Heart and Vascular Institute, University Hospitals

Cleveland, Ohio, 44106, United States

RECRUITING

Oklahoma University Health Science Center

Oklahoma City, Oklahoma, 73104, United States

COMPLETED

Integris Heart Hospital

Oklahoma City, Oklahoma, 73109, United States

COMPLETED

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

COMPLETED

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37663, United States

RECRUITING

Seton Heart Institute/ UT Austin

Austin, Texas, 78705, United States

RECRUITING

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

COMPLETED

Christus Sphon Hospital Corpus Christi-Shoreline

Corpus Christi, Texas, 78404, United States

COMPLETED

North Texas Veteran Affairs Medical Center

Dallas, Texas, 75216, United States

RECRUITING

Baylor Scott & White Research Institute

Dallas, Texas, 75226, United States

RECRUITING

El Paso Cardiovascular Care

El Paso, Texas, 79925, United States

COMPLETED

North Dallas Research Associates

McKinney, Texas, 75069, United States

COMPLETED

UT Health Sciences Center

San Antonio, Texas, 78229, United States

COMPLETED

Related Publications (9)

• 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.

  PMID: 34706553 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.

  PMID: 31686573 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.

  PMID: 29923459 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.

  PMID: 28440113 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.

  PMID: 27832850 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.

  PMID: 26839391 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.

  PMID: 25985785 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.

  PMID: 25091095 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.

  PMID: 24754288 DERIVED

Related Links

• XLPAD Registry Website

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Subhash Banerjee, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Fernandez Vazquez, MD

CONTACT

2148202928; david.fernandezvazquez@bswhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: January 1, 2013
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: February 6, 2026

Record last verified: 2025-09

Locations

US (24)