Recruiting

Observational Study

Sponsor:

Outpatient Endovascular and Interventional Society

Code:

NCT03058913

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This registry is created under the sponsorship of the Outpatient Endovascular and Interventional Society (OEIS) to monitor the clinical course and treatment outcomes of patients undergoing office-based endovascular procedures.

Conditions

Peripheral Arterial Disease

Study ID

NCT03058913

Start date

Feb 1, 2017

Status verified date

Sep, 2022

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient is 18 years of age or older;
  • Patient is identified as having undergone a percutaneous transluminal vascular intervention or attempted intervention, in an ambulatory (outpatient) facility, for the treatment of peripheral vascular disease within native arteries or bypass grafts, from the infrarenal aorta distally to the feet.

Exclusion Criteria:

  • Patient treated for a non-eligible condition or procedure
  • Diagnostic procedures without intervention or attempted interventions
  • Serious mental illness that might preclude subject's ability to comply with follow up
  • Life expectancy of less than 6 months

Study Design

Enrollment

600000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Antiplatelet Therapy (ACC/AHA/PAD Coalition) [ Time Frame: 30 days ]
  • Preventive Care and Screening: Tobacco Use [ Time Frame: 30 days ]
  • Lipid-Lowering Medications for Patients with PAD [ Time Frame: 30 days ]
  • Optimal vascular care [ Time Frame: 30 days ]
  • Preventive Care and Screening: Influenza Immunization. [ Time Frame: 30 days ]
  • Pneumonia Vaccination Status for Older Adults. [ Time Frame: 30 days ]
  • Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented. [ Time Frame: 30 days ]
  • Appropriate non-invasive arterial testing for patients with intermittent claudication who are undergoing a lower extremity peripheral vascular intervention. [ Time Frame: 30 days ]
  • Appropriate non-invasive arterial testing for patients with critical limb ischemia who are undergoing a LE peripheral vascular intervention. [ Time Frame: 30 days ]
  • Emergent transfer from an outpatient, ambulatory surgical center, or office setting. [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Dhru Bhatt

8885486347DBhatt@association-resources.com

Elizabeth Ouriel

2128786882eouriel@syntactx.com

Locations

Outpatient Endovascular Interventional Society (OEIS)

Recruiting

Hoffman Estates, Illinois, United States, 60169

Contacts

Jeff Carr

903-521-6004jeffcarr@me.com

More Information

Sponsor

Outpatient Endovascular and Interventional Society

Last update posted

Sep 28, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Outpatient Endovascular and Interventional Society on 2022-09-28.