Aorta DiseasePTANCT06022653
Asan Aorta and Peripheral Registry
An observational study of Aorta Disease and Peripheral Artery Disease, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Aorta Disease, Peripheral Artery Disease
- What is being tested?
- Treatment
- How many people
- 6,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Sep 2023to 30 Dec 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent Revascularization of Aorta or Peripheral artery from 2011 at the Peripheral Vascular Disease Center, Asan Medical Center
Who may be able to join
- 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
Show all 10Show fewer
- Peripheral artery occlusive disease
- Chronic Limb-Threatening Ischemia
- Claudication
- Acute limb ischemia
Who cannot join
- For prospective cohort, not agreeing to participate with written informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Seung-Whan Lee, MD
Seung-Whan Lee, MD
About this study
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.
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.
Read the 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.
- Conditions
- Aorta Disease, Peripheral Artery Disease
- Being tested
- Treatment
- Keywords
- Revascularization of Aorta or Peripheral artery
- Medical subject headings
- Aortic Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Also called Intervention
EVAR,TEVAR,PTA
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of death from any cause
all-cause death
Measured: 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
Measured: 10years
Secondary outcomes (8)
Rate of death from all cause including cardiovascular death
cardiovascular death,Non-cardiovascular death
Measured: 10years
Rate of stroke
Ischemic , hemorrhagic , mixed Stroke
Measured: 10years
Rate of myocardial Infarction
Spontaneous MI
Measured: 10years
Rate of vascular complication
Vascular complication
Measured: 10years
Rate of bleeding
TIMI bleeding
Measured: 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)
Measured: 10years
Rate of limb amputation
Additional limb amputation of the index limb,Additional limb amputation of the non-index limb
Measured: 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
Measured: 10years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start20 Sep 2023
- Primary completion30 Dec 2034 (estimated)
- Study completion30 Dec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Whan Lee, M.D., Ph.D., Asan Medical Center
- Investigators
- Seung-Whan Lee, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022653
- Sponsor's protocol ID
- 2023-1234
- Acronym
- PTA
- Status last verified
- Jul 2024
- First submitted
- 17 Aug 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06022653
- Acronym / sponsor ID
- PTA / 2023-1234
- Conditions
- Aorta Disease, Peripheral Artery Disease
- Keywords
- Revascularization of Aorta or Peripheral artery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 30 Dec 2034 (estimated)
- Study completion
- 30 Dec 2044 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent Revascularization of Aorta or Peripheral artery from 2011 at the Peripheral Vascular Disease Center, Asan Medical Center
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- For prospective cohort, not agreeing to participate with written informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentAlso: InterventionEVAR,TEVAR,PTA | Other | – |
Primary outcome
Rate of death from any cause
Time frame: 10years
all-cause death
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
8 secondary outcomes
Rate of death from all cause including cardiovascular death
Time frame: 10years
Rate of stroke
Time frame: 10years
Rate of myocardial Infarction
Time frame: 10years
Rate of vascular complication
Time frame: 10years
Rate of bleeding
Time frame: 10years
Success of the procedure
Time frame: 10years
Rate of limb amputation
Time frame: 10years
Rate of reintervention of aorta , reintervention of index limb or non-index limb
Time frame: 10years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Aorta Disease
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seung-Whan Lee principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorta Disease and Peripheral Artery Disease, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung hwa Lee, RN (82-2045-3398, nurse9726@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of death from any cause (time frame: 10years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.