Asan Aorta and Peripheral Registry (PTA)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease; Aorta Disease
• Intervention / Treatment: Other: Treatment

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 Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Jung hwa Lee, RN; Phone Number: 82-2045-3398; Email: nurse9726@amc.seoul.kr
• Study Contact Backup: Name: Seung-Whan Lee; Phone Number: 82 2-3010-3170; Email: seungwlee@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Principal Investigator: Seung-Whan Lee, MD
    • Sub-Investigator: Tae Oh Kim, MD
    • Contact: Seung-Whan Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Seung-Whan Lee, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): December 30, 2034
• Study Completion (Estimated): December 30, 2044

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Revascularization of Aorta or Peripheral artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 2023-1234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No