Asan Aorta and Peripheral Registry

Peripheral Artery Disease Clinical Trial

— PTA  

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06022653
• Other study ID #: 2023-1234
• Status: Not yet recruiting
• Start date: September 15, 2023
• Est. completion date: December 30, 2044

Study information

• Verified date: August 2023
• Source: Asan Medical Center
• Contact: Jung hwa Lee, RN
• Phone: 82-2045-3398
• Email: nurse9726[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Est. completion date: December 30, 2044
• Est. primary completion date: December 30, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aorta Disease
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• Treatment
EVAR,TEVAR,PTA

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of death from any cause	all-cause death	10years
Primary	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	Rate of death from all cause including cardiovascular death	cardiovascular death,Non-cardiovascular death	10years
Secondary	Rate of stroke	Ischemic , hemorrhagic , mixed Stroke	10years
Secondary	Rate of myocardial Infarction	Spontaneous MI	10years
Secondary	Rate of vascular complication	Vascular complication	10years
Secondary	Rate of bleeding	TIMI bleeding	10years
Secondary	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
Secondary	Rate of limb amputation	Additional limb amputation of the index limb,Additional limb amputation of the non-index limb	10years
Secondary	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