OEIS Outcome Data Registry

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT03058913
• Lead Sponsor: Outpatient Endovascular and Interventional Society

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antiplatelet Therapy (ACC/AHA/PAD Coalition)	30 days	To collect the clinical variables of Patients undergoing endovascular procedures in an outpatient angiograPercentage of patients with PAD that have been prescribed an antiplatelet medication at the reported encounter.
Lipid-Lowering Medications for Patients with PAD	30 days	The rate at which patients with documented peripheral artery disease have documentation of a currently prescribed antihyperlipidemic medication treatment. This may include one of the following: Statin, Bile acid sequestrants, Niacin, Ezetemibe, Fibrates, PCSK9 Inhibitors
Pneumonia Vaccination Status for Older Adults.	30 days
Preventive Care and Screening: Tobacco Use	30 days	Screening and Cessation Intervention. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user.
Optimal vascular care	30 days	This measure is a composite score of appropriate vascular care measures for treatment of PAD. This measure is a composite result of 1: Antiplatelet Therapy; 2: Preventive Care and Screening: Tobacco Use; and 3: Lipid-Lowering Medications (Statin) for Patients with PAD
Preventive Care and Screening: Influenza Immunization.	30 days
Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented.	30 days
Appropriate non-invasive arterial testing for patients with critical limb ischemia who are undergoing a LE peripheral vascular intervention.	30 days	Proportion of patients with non-invasive evaluations present/available prior to LE peripheral vascular interventions in patients with critical limb ischemia.
Appropriate non-invasive arterial testing for patients with intermittent claudication who are undergoing a lower extremity peripheral vascular intervention.	30 days	Proportion of patients with non-invasive evaluations present/available prior to lower extremity peripheral vascular interventions in patients with intermittent claudication.
Emergent transfer from an outpatient, ambulatory surgical center, or office setting.	30 days	Rate of emergent transfer from an outpatient, ASC, or office setting to an acute care facility as a result of an invasive peripheral vascular intervention.

Trial Locations

Locations (1)

Outpatient Endovascular Interventional Society (OEIS); 🇺🇸 Hoffman Estates, Illinois, United States