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)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorYonsei University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Prospective data

Age 20 years of older

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

Disqualifiers

Pregnant women or women with potential childbearing

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

Life expectancy <1 year due to comorbidity

Trial population

Patients with lower extremity artery disease

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • endovascular treatment

    Procedure/Surgery

    endovascular treatment

Treatment groups

12,000 Participants
are divided into 2 treatment groups
Group A: Retrospective cohort1 intervention
Group B: Prospective cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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