Aortoiliac Occlusive DiseaseNCT07048925
Iliac Stent-Grafts in TASC C-D Lesions
An observational study of Aortoiliac Occlusive Disease and Endovascular Treatments, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the midterm outcomes of patients with advanced aortoiliac artery narrowing (TASC C-D lesions) who were treated with covered iliac stent-grafts instead of open surgery. These patients were either too high-risk for surgery or refused it. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortoiliac Occlusive Disease, Endovascular Treatments, Peripheral Arterial Disease(PAD)
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Aug 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with peripheral artery disease and TASC C-D iliac lesions treated with covered stents between 2018 and 2023
Who may be able to join
- Patients with TASC C-D iliac artery lesions
- Procedures done within last 5 years in the same clinic
- Aged between 18-85 years
- Not eligible for open surgery or refused it
Who cannot join
- TASC A-B lesions
- Age <18 or >85
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University Faculty of Medicine
Samsun, 55090
About this study
Official title: Endovascular Treatment of TASC II C-D Iliac Artery Lesions Using Covered Stents: A Retrospective Cohort Study
This study aims to evaluate the midterm outcomes of patients with advanced aortoiliac artery narrowing (TASC C-D lesions) who were treated with covered iliac stent-grafts instead of open surgery. These patients were either too high-risk for surgery or refused it. Medical records from the past five years at a single cardiovascular surgery center in Turkey were reviewed retrospectively. The research focuses on the success rate of the procedure, complications, vessel patency, and the need for additional treatments. The results may help guide treatment decisions in similar high-risk patients who are not candidates for open vascular surgery.
Read the detailed description
This is a single-center retrospective cohort study evaluating intermediate-term outcomes of patients with aortoiliac occlusive disease who underwent endovascular treatment using covered iliac stent-grafts. The study includes patients with complex iliac artery lesions (typically classified as TASC II C or D) treated over the past five years. Open surgery was not feasible or preferred in these cases due to high surgical risk or patient refusal.The study analyzes medical records to assess technical success, symptom improvement, complication rates, vessel patency, and the need for reintervention. Results may inform the role of covered stent-grafts as a viable alternative in managing advanced aortoiliac disease in high-risk patients.
- Keywords
- TASC C-D Lesions, Iliac Stent-Graft, Non-Surgical Revascularization, Covered Stents
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical and Clinical Success of Covered Iliac Stent-Graft
Based on review of patient records over the past 5 years, including procedural success and symptom relief
Measured: Within 5 years before the study start
Secondary outcomes (1)
Complications, Patency Rates, and Reintervention Needs
Post-procedural outcomes such as restenosis, thrombosis, or need for surgical intervention
Measured: Within 5 years before the study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortoiliac Occlusive 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
- Retrospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emrah Ereren, Study chair, Samsun University Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048925
- Sponsor's protocol ID
- SUKAEK-2023/01/08
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of TASC II C-D Iliac Artery Lesions Using Covered Stents: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07048925
- Acronym / sponsor ID
- SUKAEK-2023/01/08
- Keywords
- TASC C-D Lesions, Iliac Stent-Graft, Non-Surgical Revascularization, Covered Stents
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 3 Jul 2025 (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.
This study aims to evaluate the midterm outcomes of patients with advanced aortoiliac artery narrowing (TASC C-D lesions) who were treated with covered iliac stent-grafts instead of open surgery. These patients were either too high-risk for surgery or refused it. Medical records from the past five years at a single cardiovascular surgery center in Turkey were reviewed retrospectively. The research focuses on the success rate of the procedure, complications, vessel patency, and the need for additional treatments. The results may help guide treatment decisions in similar high-risk patients who are not candidates for open vascular surgery.
Detailed description
This is a single-center retrospective cohort study evaluating intermediate-term outcomes of patients with aortoiliac occlusive disease who underwent endovascular treatment using covered iliac stent-grafts. The study includes patients with complex iliac artery lesions (typically classified as TASC II C or D) treated over the past five years. Open surgery was not feasible or preferred in these cases due to high surgical risk or patient refusal.The study analyzes medical records to assess technical success, symptom improvement, complication rates, vessel patency, and the need for reintervention. Results may inform the role of covered stent-grafts as a viable alternative in managing advanced aortoiliac disease in high-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with peripheral artery disease and TASC C-D iliac lesions treated with covered stents between 2018 and 2023
Key inclusion criteria (4 listed)
- Patients with TASC C-D iliac artery lesions
- Procedures done within last 5 years in the same clinic
- Aged between 18-85 years
- Not eligible for open surgery or refused it
Key exclusion criteria (2 listed)
- TASC A-B lesions
- Age <18 or >85
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical and Clinical Success of Covered Iliac Stent-Graft
Time frame: Within 5 years before the study start
Based on review of patient records over the past 5 years, including procedural success and symptom relief
1 secondary outcome
Complications, Patency Rates, and Reintervention Needs
Time frame: Within 5 years before the study start
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 20 Jul 2025.
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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. This study is not recruiting at the moment.
Emrah Ereren study chair
Samsun University Faculty of medicine
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 Aortoiliac Occlusive Disease and Endovascular Treatments, run by Samsun University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical and Clinical Success of Covered Iliac Stent-Graft (time frame: Within 5 years before the study start). 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 20 Jul 2025.