Trial record 7 of 217 for:    Open Studies | "Peripheral Vascular Diseases"

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

This study is currently recruiting participants.
Verified July 2013 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Subhash Banerjee, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01904851
First received: July 17, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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. 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 2,174 patients will be enrolled at approximately 20 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.


Condition
Peripheral Arterial Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Target Follow-Up Duration: 12 Months
Official Title: Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Target Limb Revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Target Lesion or Vessel Revascularization or Surgical Revascularization/Amputation of Target Limb


Estimated Enrollment: 2174
Study Start Date: January 2013
Estimated Study Completion Date: January 2033
Estimated Primary Completion Date: January 2033 (Final data collection date for primary outcome measure)
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01904851

Contacts
Contact: Atif Mohammad, MD 2148571556 atif.mohammad@utsouthwestern.edu
Contact: Karan Sarode, MA 2146977808 karan.sarode@utsouthwestern.edu

Locations
United States, Colorado
University of Colorado Anschustz Medical Campus Recruiting
Denver, Colorado, United States, 80045
Principal Investigator: Thomas Tsai, MD         
United States, Illinois
Loyola University Medical Center Recruiting
Chicago, Illinois, United States, 60153
Principal Investigator: Robert S Dieter, MD         
United States, Indiana
Indiana University Health Ball Memorial Hospital Recruiting
Muncie, Indiana, United States, 47303
Principal Investigator: M. Ishti Ali, MD         
United States, Iowa
Mid West Cardiovascular Research Foundation Recruiting
Davenport, Iowa, United States, 52803
Principal Investigator: Nicolas Shammas, MD         
United States, Missouri
St. Louis University Medical Center Recruiting
St. Louis, Missouri, United States, 63104
Principal Investigator: Andrew Klein, MD         
United States, Oklahoma
Oklahoma University Health Science Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Mazen Abu-Fadel, MD         
United States, Texas
Seton Heart Institute Recruiting
Austin, Texas, United States, 78705
Principal Investigator: Osvaldo Gigliotti, MD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Subhash Banerjee, MD         
North Texas Veteran Affairs Medical Center Recruiting
Dallas, Texas, United States, 75216
Principal Investigator: Subhash Banerjee, MD         
UT Health Sciences Center Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Anand Prasad, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Boston Scientific Corporation
Investigators
Principal Investigator: Subhash Banerjee, MD University of Texas
  More Information

Additional Information:
No publications provided

Responsible Party: Subhash Banerjee, Dr, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01904851     History of Changes
Other Study ID Numbers: 052012-093
Study First Received: July 17, 2013
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Peripheral Arterial Disease
Stents
Registry
Angioplasty
Endovascular Procedures

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014