PTA: Asan Aorta and Peripheral Registry

• Sponsor: Asan Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06022653
• Collaborator: (none)
• Enrollment: 6,000
• Location: 1
• Anticipated Duration (Months): 255.5
• Patients Per Site Per Month: 23.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aorta Disease; Peripheral Artery Disease	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 Design

• Study Type: Observational
• Anticipated Enrollment: 6000 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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.
• Anticipated Study Start Date: Sep 15, 2023
• Anticipated Primary Completion Date: Dec 30, 2034
• Anticipated Study Completion Date: Dec 30, 2044

Outcome Measures

Primary Outcome Measures

1. Rate of death from any cause [10years]

   all-cause death

2. 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

Secondary Outcome Measures

1. Rate of death from all cause including cardiovascular death [10years]

   cardiovascular death,Non-cardiovascular death

2. Rate of stroke [10years]

   Ischemic , hemorrhagic , mixed Stroke

3. Rate of myocardial Infarction [10years]

   Spontaneous MI

4. Rate of vascular complication [10years]

   Vascular complication

5. Rate of bleeding [10years]

   TIMI bleeding

6. 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)

7. Rate of limb amputation [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 [10years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Asan Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Whan Lee, M.D., Ph.D., Principal investigator, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT06022653
• Other Study ID Numbers: 2023-1234
• First Posted: Sep 5, 2023
• Last Update Posted: Sep 5, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seung-Whan Lee, M.D., Ph.D., Principal investigator, Asan Medical Center: Revascularization of Aorta or Peripheral artery
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

No Results Posted as of Sep 5, 2023