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NCT Number: NCT06022653

Asan Aorta and Peripheral Registry

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

Location status: Recruiting

Location contact

Seung-Whan Lee, MD

CONTACT

Seung-Whan Lee, MD

PRINCIPAL_INVESTIGATOR

Tae Oh Kim, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Aneurysm
  • 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

Treatment and study plan

Treatment

Other

EVAR,TEVAR,PTA

Other names: Intervention

Primary outcomes

  1. Rate of death from any cause

    Time frame: 10years

    all-cause death

  2. 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

Secondary outcomes

  1. Rate of death from all cause including cardiovascular death

    Time frame: 10years

    cardiovascular death,Non-cardiovascular death

  2. Rate of stroke

    Time frame: 10years

    Ischemic , hemorrhagic , mixed Stroke

  3. Rate of myocardial Infarction

    Time frame: 10years

    Spontaneous MI

  4. Rate of vascular complication

    Time frame: 10years

    Vascular complication

  5. Rate of bleeding

    Time frame: 10years

    TIMI bleeding

  6. Success of the procedure

    Time frame: 10years

    PTA (target artery path) TEVAR and EVAR if aneurysm is diagnosed (the endograft is deployed accurately and the aneurysm is excluded from the circulation), if dissection is diagnosed(closure of the primary entry tear (i.e. absence of type Ia endoleak) and induction of false lumen thrombosis)

  7. Rate of limb amputation

    Time frame: 10years

    Additional limb amputation of the index limb,Additional limb amputation of the non-index limb

  8. Rate of reintervention of aorta , reintervention of index limb or non-index limb

    Time frame: 10years

    Reintervention of aorta , reintervention of index limb or non-index limb

Study contacts

Contact information is provided by the study sponsor or research team.

Jung hwa Lee, RN

CONTACT

[email protected]

82-2045-3398

Seung-Whan Lee

CONTACT

[email protected]

82 2-3010-3170

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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.

Acronym: PTA

Important dates

Study start
2023
Primary completion
2034
Study completion
2044
First posted
Sep 5, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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