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Clinical Trials/NCT06022653
NCT06022653
Recruiting
N/A

Evaluation of Patients Underwent Revascularization of Aorta or Peripheral Artery at the Peripheral Vascular Disease Center, Asan Medical Center; A Single Center, Retrospective/Prospective Observational Study.

Asan Medical Center1 site in 1 country6,000 target enrollmentSeptember 20, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aorta Disease
Sponsor
Asan Medical Center
Enrollment
6000
Locations
1
Primary Endpoint
Rate of major Adverse Limb Events
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to evaluate the clinical results of patients who received revascularization of the aorta and peripheral artery at Asan Medical Center.

Detailed Description

This study is a single center retrospective and prospective observational study to evaluate the clinical results of patients who received revascularization of the aorta and peripheral artery at asan medical center. Data will be collected on approximately 6,000 subjects in asan medical center. Individuals will be followed up at 1, 6, and 12 months, 3, 5years up to 10 years by telephone call or hospital visit. Data collected during all follow-up visits will include a composite of major adverse limb events, or death from any cause.

Registry
clinicaltrials.gov
Start Date
September 20, 2023
End Date
December 30, 2044
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seung-Whan Lee, M.D., Ph.D.

Principal investigator

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients underwent Revascularization of Aorta or Peripheral artery from 2011 at the Peripheral Vascular Disease Center, Asan Medical Center
  • Patients with aortic and peripheral artery disease are defined as:
  • Thoacic aorta disease/ abdominal aorta disease
  • Aortic dissection
  • Penetrating aortic ulcer
  • Peripheral artery occlusive disease
  • Chronic Limb-Threatening Ischemia
  • Claudication
  • Acute limb ischemia

Exclusion Criteria

  • For prospective cohort, not agreeing to participate with written informed consent form

Outcomes

Primary Outcomes

Rate of major Adverse Limb Events

Time Frame: 10years

above-ankle amputation of the index limb,major index-limb reintervention including new bypass,interposition graft revision,thrombectomy, or thrombolysis

Rate of death from any cause

Time Frame: 10years

all-cause death

Secondary Outcomes

  • Rate of death from all cause including cardiovascular death(10years)
  • Rate of bleeding(10years)
  • Success of the procedure(10years)
  • Rate of limb amputation(10years)
  • Rate of stroke(10years)
  • Rate of reintervention of aorta , reintervention of index limb or non-index limb(10years)
  • Rate of myocardial Infarction(10years)
  • Rate of vascular complication(10years)

Study Sites (1)

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