NCT06022653

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
227mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Sep 2023Dec 2044

First Submitted

Initial submission to the registry

August 17, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2034

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2044

Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

11.3 years

First QC Date

August 17, 2023

Last Update Submit

July 16, 2024

Conditions

Keywords

Revascularization of Aorta or Peripheral artery

Outcome Measures

Primary Outcomes (2)

  • Rate of death from any cause

    all-cause death

    10years

  • Rate of major Adverse Limb Events

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

    10years

Secondary Outcomes (8)

  • Rate of death from all cause including cardiovascular death

    10years

  • Rate of stroke

    10years

  • Rate of myocardial Infarction

    10years

  • Rate of vascular complication

    10years

  • Rate of bleeding

    10years

  • +3 more secondary outcomes

Interventions

EVAR,TEVAR,PTA

Also known as: Intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent Revascularization of Aorta or Peripheral artery from 2011 at the Peripheral Vascular Disease Center, Asan Medical Center

You may qualify if:

  • 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
  • Aneurysm
  • Aortic dissection
  • Penetrating aortic ulcer
  • Peripheral artery occlusive disease
  • Chronic Limb-Threatening Ischemia
  • Claudication
  • Acute limb ischemia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Aortic DiseasesPeripheral Arterial Disease

Interventions

TherapeuticsMethods

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Seung-Whan Lee

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 17, 2023

First Posted

September 5, 2023

Study Start

September 20, 2023

Primary Completion (Estimated)

December 30, 2034

Study Completion (Estimated)

December 30, 2044

Last Updated

July 17, 2024

Record last verified: 2024-07

Locations