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)

Peripheral Arterial Disease(PAD) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02748226
• Other study ID #: 4-2013-0463
• Status: Recruiting
• Start date: September 30, 2013
• Est. completion date: July 31, 2027

Study information

• Verified date: June 2024
• Source: Yonsei University
• Contact: Young-Guk Ko, PhD
• Phone: 02)-2228-8460
• Email: ygko[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease(PAD)
• Peripheral Vascular Diseases

Intervention

Procedure:
• endovascular treatment
endovascular treatment

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	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.	12 months
Secondary	Target lesion revascularization (TLR)	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.	12 months