Asan Aorta and Peripheral Registry

Recruiting

• Conditions: Peripheral Artery Disease; Aorta Disease

• Registration Number: NCT06022653
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-05
• Study Start: 2023-09-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2034-12-30
• Study Completion: 2044-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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

1. Aneurysm
2. Aortic dissection
3. Penetrating aortic ulcer

Peripheral artery occlusive disease

1. Chronic Limb-Threatening Ischemia
2. Claudication
3. Acute limb ischemia

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of major Adverse Limb Events	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	10years	all-cause death

Secondary Outcome Measures

Name	Time	Method
Rate of death from all cause including cardiovascular death	10years	cardiovascular death,Non-cardiovascular death
Rate of bleeding	10years	TIMI bleeding
Success of the procedure	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)
Rate of limb amputation	10years	Additional limb amputation of the index limb,Additional limb amputation of the non-index limb
Rate of stroke	10years	Ischemic , hemorrhagic , mixed Stroke
Rate of reintervention of aorta , reintervention of index limb or non-index limb	10years	Reintervention of aorta , reintervention of index limb or non-index limb
Rate of myocardial Infarction	10years	Spontaneous MI
Rate of vascular complication	10years	Vascular complication

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of