Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes (XLPAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904851
Recruitment Status : Recruiting
First Posted : July 22, 2013
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date July 17, 2013
First Posted Date July 22, 2013
Last Update Posted Date May 19, 2020
Study Start Date January 2013
Estimated Primary Completion Date January 2033   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2013)
Target Limb Revascularization [ Time Frame: 12 months ]
Target Lesion or Vessel Revascularization or Surgical Revascularization/Amputation of Target Limb
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes
Official Title Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease
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. 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. 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. 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.

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:

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition Peripheral Arterial Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 10, 2016)
14000
Original Estimated Enrollment
 (submitted: July 17, 2013)
2174
Estimated Study Completion Date January 2033
Estimated Primary Completion Date January 2033   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Failed Revascularization Attempt
  • Surgical Bypass
  • Only Iliac Artery Treated
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Ishita Tejani, BDS,MS,MSPH 2148573048 ishita.tejani@utsouthwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01904851
Other Study ID Numbers STU 052012-093
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor University of Texas Southwestern Medical Center
Collaborators Boston Scientific Corporation
Investigators
Principal Investigator: Subhash Banerjee, MD University of Texas
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2020