Peripheral Arterial DiseaseXLPADNCT01904851

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes

An observational study of Peripheral Arterial Disease, run by Baylor Research Institute at 24 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Peripheral Arterial Disease
How many people: 14,000 participants
Where: 24 sitesUnited States
Study dates: Jan 2013to Jan 2033
How long will I take part?: 12 Months
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

Surgical Bypass

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

David Fernandez Vazquez, MD contact

2148202928

david.fernandezvazquez@bswhealth.org

City, postcode or hospital

Sites recruiting now only

24 sites in 1 country

United States24 sites, 7 recruiting

Emory University
Atlanta, Georgia, 30322
Completed
Seton Heart Institute/ UT Austin
Austin, Texas, 78705
Sarah J Benedict, 512-324-9999 ext. 18171, sarah.benedict@ascension.org
Peter Monteleone, MD
Recruiting
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
Completed
VA Boston Healthcare System
Boston, Massachusetts, 02301
Completed
Loyola University Medical Center
Chicago, Illinois, 60153
Completed
Cleveland Clinic
Cleveland, Ohio, 38732
Aravinda Nanjundappa, MD
Recruiting
Harrington Heart and Vascular Institute, University Hospitals
Cleveland, Ohio, 44106
Mehdi Shishehbor, MD
Recruiting
Christus Sphon Hospital Corpus Christi-Shoreline
Corpus Christi, Texas, 78404
Completed
North Texas Veteran Affairs Medical Center
Dallas, Texas, 75216
Shirling Tsai, MD
Recruiting
Baylor Scott & White Research Institute
Dallas, Texas, 75226
David Fernandez Vazquez, MD
Subhash Banerjee, MD
Recruiting
Mid West Cardiovascular Research Foundation
Davenport, Iowa, 52803
Completed
Denver VAMC
Denver, Colorado, 80220
Completed
Detroit Medical Center
Detroit, Michigan, 48201
Chadi Alraies, MD
Recruiting
El Paso Cardiovascular Care
El Paso, Texas, 79925
Completed
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37663
Gaurav Rana, MD
Recruiting
Arkansas Heart Institute
Little Rock, Arkansas, 72211
Completed
North Dallas Research Associates
McKinney, Texas, 75069
Completed
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, 47303
Completed
Carolina East Health System
New Bern, North Carolina, 28560
Completed
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104
Completed
Integris Heart Hospital
Oklahoma City, Oklahoma, 73109
Completed
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Completed
UT Health Sciences Center
San Antonio, Texas, 78229
Completed
St. Louis University Medical Center
St Louis, Missouri, 63104
Completed

Other trials in United States

About this study

Official title: Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease

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)
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)
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)

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.

Read the detailed description

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:

Background Information
Site, attending operator, and month-year of procedure
Patient height, weight, age, race, and sex
Rutherford claudication category, left and right ankle brachial index, ambulatory status, claudication free distance
Risk factors such as diabetes, hypertension, hyperlipidemia, and prior history of lower extremity percutaneous intervention
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)

Access site relative to target limb, sheath size, target limb (left or right)
Target vessel: superficial femoral artery, popliteal artery, peroneal artery, anterior tibial artery, or posterior tibial artery
Which, if any, Iliac arteries were treated during procedure
Target lesion location (ostial, proximal, medial, distal), estimated vessel diameter, estimated vessel length
Lesion characteristics (heavily calcified, diffuse, thrombus, chronic total occlusion (CTO), in-stent restenosis, restenosis post balloon angioplasty, profunda femoris disease)
Planned revascularization strategy: stent or non-stent based

IIa) CTO Characteristics (Only required for CTO lesions)

Type of proximal and distal stumps, sidebranches present, collateral filling of distal vessel, tortuosity, prior attempt to cross CTO
Antegrade or retrograde crossing strategy, crossing technique, number of attempts
Crossing devices used, microcatheters used, sub-intimal re-entry devices used (if any), embolic protection device used

III) Intervention Details

Atherectomy device used (Cutting Balloon, TurboHawk, SilverHawk, Rotablator, Laser)
Pre and post-dilation balloon information (type, length, width, average atmospheric pressure, number of inflations)
Stent information (indication for stents, length, width, maximum pressure, overlapping with previous stents)
Aspiration/Thrombectomy used, thrombolytic therapy used
Percent change in stenosis and TIMI flows (before and after)

IV) Outcomes

Technical success (<30% residual stenosis), procedural success (<30% residual stenosis without complications), and case comments
Anti-coagulation used, medical therapy (plavix, aspirin, lipid lowering therapy, angiotensin receptor blocker, beta blocker, cilostazol, trental, insulin, oral hypoglycemics)
Duration of procedure, fluoroscopy (amount used, type, and time)
Any procedural complications
Follow-Up
Month and year of follow-up
Rutherford category, left and right ankle brachial index, claudication-free distance, ambulatory status, change in claudication (improved, same, or worsened)
Duplex ultrasound performed
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.

Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease, Stents, Registry, Angioplasty, Endovascular Procedures
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01904851
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Target Limb Revascularization
Target Lesion or Vessel Revascularization or Surgical Revascularization/Amputation of Target Limb
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jan 2033

First posted22 Jul 2013 (estimated)
Study startJan 2013
Primary completionJan 2033 (estimated)
Study completionJan 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 14,000 participants (estimated)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT01904851
Sponsor's protocol ID: STU 052012-093
Acronym: XLPAD
Status last verified: Sep 2025
First submitted: 17 Jul 2013
Last updated: 6 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 34706553
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.
PubMed 31686573
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.
PubMed 29923459
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.
PubMed 28440113
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.
PubMed 27832850
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.
PubMed 26839391
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.
PubMed 25985785
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.
PubMed 25091095
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.
PubMed 24754288

Interested in taking part?

David Fernandez Vazquez, MD

2148202928

david.fernandezvazquez@bswhealth.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease
ClinicalTrials.gov ID: NCT01904851
Acronym / sponsor ID: XLPAD / STU 052012-093
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease, Stents, Registry, Angioplasty, Endovascular Procedures
Study type: Observational
Recruitment status: Recruiting
Enrolment: 14,000 participants (estimated)
Lead sponsor: Baylor Research InstituteUniversity, hospital or other
Study start: Jan 2013
Primary completion: Jan 2033 (estimated)
Study completion: Jan 2033 (estimated)
First posted: 22 Jul 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)
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)
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)

Detailed description

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

Background Information
Site, attending operator, and month-year of procedure
Patient height, weight, age, race, and sex
Rutherford claudication category, left and right ankle brachial index, ambulatory status, claudication free distance
Risk factors such as diabetes, hypertension, hyperlipidemia, and prior history of lower extremity percutaneous intervention
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)

Access site relative to target limb, sheath size, target limb (left or right)
Target vessel: superficial femoral artery, popliteal artery, peroneal artery, anterior tibial artery, or posterior tibial artery
Which, if any, Iliac arteries were treated during procedure
Target lesion location (ostial, proximal, medial, distal), estimated vessel diameter, estimated vessel length
Lesion characteristics (heavily calcified, diffuse, thrombus, chronic total occlusion (CTO), in-stent restenosis, restenosis post balloon angioplasty, profunda femoris disease)
Planned revascularization strategy: stent or non-stent based

IIa) CTO Characteristics (Only required for CTO lesions)

Type of proximal and distal stumps, sidebranches present, collateral filling of distal vessel, tortuosity, prior attempt to cross CTO
Antegrade or retrograde crossing strategy, crossing technique, number of attempts
Crossing devices used, microcatheters used, sub-intimal re-entry devices used (if any), embolic protection device used

III) Intervention Details

Atherectomy device used (Cutting Balloon, TurboHawk, SilverHawk, Rotablator, Laser)
Pre and post-dilation balloon information (type, length, width, average atmospheric pressure, number of inflations)
Stent information (indication for stents, length, width, maximum pressure, overlapping with previous stents)
Aspiration/Thrombectomy used, thrombolytic therapy used
Percent change in stenosis and TIMI flows (before and after)

IV) Outcomes

Technical success (<30% residual stenosis), procedural success (<30% residual stenosis without complications), and case comments
Anti-coagulation used, medical therapy (plavix, aspirin, lipid lowering therapy, angiotensin receptor blocker, beta blocker, cilostazol, trental, insulin, oral hypoglycemics)
Duration of procedure, fluoroscopy (amount used, type, and time)
Any procedural complications
Follow-Up
Month and year of follow-up
Rutherford category, left and right ankle brachial index, claudication-free distance, ambulatory status, change in claudication (improved, same, or worsened)
Duplex ultrasound performed
Adverse events experienced (death, myocardial infarction, stroke, stent thrombosis, stent fracture, angiography, repeat endovascular intervention, surgical revascularization, amputation in target or non-target limb)

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 12 Months
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with diagnosed peripheral arterial disease who underwent endovascular intervention, and received either a stent or non-stent based treatment.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Surgical Bypass

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Target Limb Revascularization
Time frame: 12 months
Target Lesion or Vessel Revascularization or Surgical Revascularization/Amputation of Target Limb

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
Derived from this study: PubMed 34706553Patel 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.
Derived from this study: PubMed 31686573Armstrong 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.
Derived from this study: PubMed 29923459Kokkinidis 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.
Derived from this study: PubMed 28440113Shammas 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.
Derived from this study: PubMed 27832850Banerjee 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.
Derived from this study: PubMed 26839391Banerjee 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.
Derived from this study: PubMed 25985785Banerjee 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.
Derived from this study: PubMed 25091095Banerjee 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.
Derived from this study: PubMed 24754288Banerjee 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.
XLPAD Registry WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

David Fernandez Vazquez, MD contact

2148202928

david.fernandezvazquez@bswhealth.org

Subhash Banerjee, MD principal investigator

Baylor Research Institute

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Baylor Research Institute at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Fernandez Vazquez, MD (2148202928, david.fernandezvazquez@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Limb Revascularization (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01904851, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.