OEIS Outcome Data Registry

Peripheral Arterial Disease Clinical Trial

Official title:

OEIS (Outpatient Endovascular and Interventional Society) Outcome Data Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03058913
• Other study ID #: 2016-OEIS-01
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: December 2025

Study information

• Verified date: September 2022
• Source: Outpatient Endovascular and Interventional Society
• Contact: Dhru Bhatt
• Phone: 8885486347
• Email: DBhatt[@]association-resources.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
United States	Outpatient Endovascular Interventional Society (OEIS)	Hoffman Estates	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Outpatient Endovascular and Interventional Society	Syntactx

Country where clinical trial is conducted

United States, 

References & Publications (5)

Carey K, Burgess JF Jr, Young GJ. Hospital competition and financial performance: the effects of ambulatory surgery centers. Health Econ. 2011 May;20(5):571-81. doi: 10.1002/hec.1617. — View Citation

Kutscher B. Outpatient care takes the inside track. Mod Healthc. 2012 Aug 6;42(32):24-6. — View Citation

Lapetina EM, Armstrong EM. Preventing errors in the outpatient setting: a tale of three states. Health Aff (Millwood). 2002 Jul-Aug;21(4):26-39. — View Citation

Lin PH, Yang KH, Kollmeyer KR, Uceda PV, Ferrara CA, Feldtman RW, Caruso J, Mcquade K, Richmond JL, Kliner CE, Egan KE, Kim W, Saines M, Leichter R, Ahn SS. Treatment outcomes and lessons learned from 5134 cases of outpatient office-based endovascular procedures in a vascular surgical practice. Vascular. 2017 Apr;25(2):115-122. doi: 10.1177/1708538116657506. Epub 2016 Jul 9. — View Citation

Murer CG. Significant changes for ASC payment systems. Rehab Manag. 2007 Nov;20(9):42, 44-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiplatelet Therapy (ACC/AHA/PAD Coalition)	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.	30 days
Primary	Preventive Care and Screening: Tobacco Use	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.	30 days
Primary	Lipid-Lowering Medications for Patients with PAD	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	30 days
Primary	Optimal vascular care	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	30 days
Primary	Preventive Care and Screening: Influenza Immunization.		30 days
Primary	Pneumonia Vaccination Status for Older Adults.		30 days
Primary	Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented.		30 days
Primary	Appropriate non-invasive arterial testing for patients with intermittent claudication who are undergoing a lower extremity peripheral vascular intervention.	Proportion of patients with non-invasive evaluations present/available prior to lower extremity peripheral vascular interventions in patients with intermittent claudication.	30 days
Primary	Appropriate non-invasive arterial testing for patients with critical limb ischemia who are undergoing a LE peripheral vascular intervention.	Proportion of patients with non-invasive evaluations present/available prior to LE peripheral vascular interventions in patients with critical limb ischemia.	30 days
Primary	Emergent transfer from an outpatient, ambulatory surgical center, or office setting.	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.	30 days