Korean Vascular Intervention Society Multicenter Registry Study on Outcomes of Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA): (A Retrospective & Prospective Observational Study)

Recruiting

• Conditions: Peripheral Arterial Disease(PAD)
• Interventions: Procedure: endovascular treatment

• Registration Number: NCT02748226
• Lead Sponsor: Yonsei University

Brief Summary

1. Study design: multicenter retrospective and prospective observational study

2. Study Cohort :

1. Retrospective cohort: This cohort retrospectively enrolls patients with lower extremity artery disease who underwent endovascular treatment from January 2006 to the date of approval by IRB in the participating hospitals. Informed consent was waived by IRB.

2. Prospective cohort: This cohort prospectively enrolls patients with lower extremity artery disease who undergo endovascular treatment from the date of approval by IRB to July, 2018 in the participating hospitals. Informed consent will be obtained prior to enrollment.

3. Baseline clinical and lesion characteristics, procedural and post-procedural data, clinical outcomes, hemodynamic, and imaging follow-up data are investigated. Primary patency and target lesion revascularization rates of the total cohort and patient subgroups are evaluated. Risk factors of restenosis and target lesion revascularization are determined.

Detailed Description

This is an observational study. The study includes patients who underwent endovascular treatments for lower extremity artery diseases and investigates immediate and late outcomes of the treatments. The investigator does not assign any specific interventions.

Study Timeline

• Study Start: 2013-09-30
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-09
• Last Update Posted: 2024-06-11
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

Inclusion Criteria

• Retrospective data Patients who underwent or attempted endovascular treatment for symptomatic peripheral artery disease from January 2006 until IRB approval date

• Prospective data

  1. Age 20 years of older

  2. Patients in the treatment or trying about symptomatic peripheral artery disease from IRB approval date

  3. Symptomatic peripheral artery disease:

     • Intermittent claudication (Rutherford category 1 to 3)
     • Critical limb ischemia (Rutherford category 4 to 6)

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Exclusion Criteria

1. Pregnant women or women with potential childbearing
2. Moderate Alzheimer's disease, mental illness or neurological disease of more than those who can not understand the purpose of this clinical trials and Methods
3. Life expectancy <1 year due to comorbidity

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective cohort	endovascular treatment	This cohort retrospectively enrolls patients with lower extremity artery disease who underwent endovascular treatment from January 2006 to the date of approval by IRB in the participating hospitals.
Prospective cohort	endovascular treatment	This cohort prospectively enrolls patients with lower extremity artery disease who undergo endovascular treatment from the date of approval by IRB to July, 2018 in the participating hospitals.

Primary Outcome Measures

Name	Time	Method
Primary patency	12 months	Primary patency is defined as freedom from more than 50% restenosis based on CT angiography, duplex ultrasound or catheter-based angiography or from clinically-driven target lesion revascularization.

Secondary Outcome Measures

Name	Time	Method
Target lesion revascularization (TLR)	12 months	Any re-intervention within the target lesion due to symptom aggravation or drop of ankle brachial index (ABI) \>0.15 when compared to post procedure baseline.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of