Aortoiliac AtherosclerosisNCT06260475
IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions
An observational study of Aortoiliac Atherosclerosis and Aortoiliac Occlusive Disease, run by Universidade do Porto at 2 sites in Portugal.
Trial summary
This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortoiliac Atherosclerosis, Aortoiliac Occlusive Disease, Aortoiliac Atherosclerosis With Gangrene
- What is being tested?
- Aortobifemoral bypass and aortoiliac stenting
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Mar 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing revascularization of the aorto-iliac sector for peripheral arterial disease at any of the center in study starting in January 2016 until December 2023.A consecutive sample will be prepared, containing all patients at the recruiting centers, fulfilling the following criteria
Who may be able to join
- Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12).
- Age >18 years old
Who cannot join
- Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter >25 mm)
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Centro Hospitalar Universitário de São João, EPE
Porto, 4200-319
Joao Rocha-Neves, +351910486230, joaorochaneves@hotmail.com
Faculdade de Medicina da Universidade do Porto
Porto, 4200-319
About this study
This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II
Read the detailed description
Open surgery repair with Aortobifemoral Bypass (ABF) remains the gold standard revascularization technique in patients with lifestyle-limiting intermittent claudication (IC) and chronic limb-threatening ischemia due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type D lesions
The ABF procedure has proven safe, effective, and durable, particularly considering its high long-term patency rates (85%-90% at five years and 75%-80% at ten years) despite its significant peri-operative associated morbidity (1). On the other hand, endovascular treatment (EVT) offers an attractive alternative with durable results (four- or 5-year primary and secondary patency rates ranged from 60% to 86% and 80% to 98%, respectively), especially in less extensive AIOD, while also providing less perioperative morbidity, making it generally preferable for patients with more severe comorbid conditions.
Thus, surgical approaches to extensive AIOD have changed considerably over the last years, primarily due to increased EVT, particularly with the uncovered aortoiliac stenting (AIS). While TASC II provides an anatomical framework to compare therapeutic techniques, the advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies. It is attractive for patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to ABF
This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II).
- Conditions
- Aortoiliac Atherosclerosis, Aortoiliac Occlusive Disease, Aortoiliac Atherosclerosis With Gangrene, Aortoiliac Atherosclerosis Without Gangrene, Aortoiliac Obstruction, Peripheral Arterial Disease
- Being tested
- Aortobifemoral bypass, aortoiliac stenting
- Keywords
- peripheral artery disease;, aortobifemoral bypass;, aortoiliac stenting;, preoperative care;
- Medical subject headings
- Leriche Syndrome, Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortobifemoral bypassProcedure or surgery
Also called aortobiliac bypass
Open surgery with aortic and iliac reconstruction
aortoiliac stentingProcedure or surgery
Also called Percutaneous transluminal aortoiliac stenting; Endovascular treatment of aortoiliac occlusive disease
Endovascular reconstruction of aortic and iliac arterial obstruction:
Balloon angioplasty may be performed initially to dilate the narrowed segment of the iliac artery.
Subsequently, a stent delivery system is advanced over the wire and positioned across the lesion.
The stent is deployed under fluoroscopic guidance to expand and scaffold the diseased artery, restoring blood flow.
Vascular - iliac dedicated Stent - any brand
| Study group | Role | What they receive |
|---|---|---|
| Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease | Chronic limb-threatening ischemia or claudicants due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type C and D lesions Receives: Procedure: Aortobifemoral bypass; Procedure: aortoiliac stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Amputation
Amputation above the ankle
Measured: through study completion, an average of 3 years
Cardiovascular Death
Death from cardiovascular disease
Measured: through study completion, an average of 3 years
acute myorcardial infartion
According to the 4th definition of Myocardial infarction
Measured: through study completion, an average of 3 years
Secondary outcomes (3)
Major Adverse Limb Events
Amputation above the ankle, arterial thrombosis of the limb, binary restenosis
Measured: through study completion, an average of 3 years
Major adverse cardiovascular events
acute myocardial infarction; acute heart faillure, cardiovascular death, coronary reintervention
Measured: through study completion, an average of 3 years
Death
Diagnosed by a physician
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortoiliac AtherosclerosisStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Centre of Serbia, University of Padova, University of Bari, University of Trieste, University of Nis, Centro Hospitalar de Vila Nova de Gaia/Espinho, Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro, Centro Hospitalar do Porto
- Responsible party
- Principal investigator, João Rocha Neves, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260475
- Sponsor's protocol ID
- IUA - 246-18
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The anonymity and confidentiality of participants will be safeguarded. The patient will be entered without any reference to their name. The participant number will correspond to the clinical information in a separate database, which will only be used for the proposed objective after supervision by the PI and Supervisor. For analysis purposes, the participant number will be deleted. All information entered in the database will be constant in the clinical process. The results may be published in a scientific journal and/or congress. Rules of Ethical Conduct and Good Practices will be observed to ensure compliance with the precepts of the Declaration of Helsinki, the Convention on Human Rights and Biomedicine, the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practices.
Publications
Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg. 2010 Nov;52(5):1376-83. doi: 10.1016/j.jvs.2010.04.080.
PubMed 20598474Groot Jebbink E, Holewijn S, Slump CH, Lardenoije JW, Reijnen MMPJ. Systematic Review of Results of Kissing Stents in the Treatment of Aortoiliac Occlusive Disease. Ann Vasc Surg. 2017 Jul;42:328-336. doi: 10.1016/j.avsg.2017.01.009. Epub 2017 Apr 6.
PubMed 28390920
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions
- ClinicalTrials.gov ID
- NCT06260475
- Acronym / sponsor ID
- IUA - 246-18
- Conditions
- Aortoiliac Atherosclerosis, Aortoiliac Occlusive Disease, Aortoiliac Atherosclerosis With Gangrene, Aortoiliac Atherosclerosis Without Gangrene, Aortoiliac Obstruction, Peripheral Arterial Disease
- Keywords
- peripheral artery disease;, aortobifemoral bypass;, aortoiliac stenting;, preoperative care;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Clinical Centre of Serbia, University of Padova, University of Bari, University of Trieste, University of Nis, Centro Hospitalar de Vila Nova de Gaia/Espinho, Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro, Centro Hospitalar do Porto
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Feb 2024 (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 clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II
Detailed description
Open surgery repair with Aortobifemoral Bypass (ABF) remains the gold standard revascularization technique in patients with lifestyle-limiting intermittent claudication (IC) and chronic limb-threatening ischemia due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type D lesions
The ABF procedure has proven safe, effective, and durable, particularly considering its high long-term patency rates (85%-90% at five years and 75%-80% at ten years) despite its significant peri-operative associated morbidity (1). On the other hand, endovascular treatment (EVT) offers an attractive alternative with durable results (four- or 5-year primary and secondary patency rates ranged from 60% to 86% and 80% to 98%, respectively), especially in less extensive AIOD, while also providing less perioperative morbidity, making it generally preferable for patients with more severe comorbid conditions.
Thus, surgical approaches to extensive AIOD have changed considerably over the last years, primarily due to increased EVT, particularly with the uncovered aortoiliac stenting (AIS). While TASC II provides an anatomical framework to compare therapeutic techniques, the advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies. It is attractive for patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to ABF
This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease | – | Procedure: Aortobifemoral bypass, Procedure: aortoiliac stentingChronic limb-threatening ischemia or claudicants due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type C and D lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing revascularization of the aorto-iliac sector for peripheral arterial disease at any of the center in study starting in January 2016 until December 2023.A consecutive sample will be prepared, containing all patients at the recruiting centers, fulfilling the following criteria
Key inclusion criteria (2 listed)
- Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12).
Key exclusion criteria (1 listed)
- Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter >25 mm)
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 |
|---|---|---|
| Aortobifemoral bypassAlso: aortobiliac bypassOpen surgery with aortic and iliac reconstruction | Procedure or surgery | Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease |
| aortoiliac stentingAlso: Percutaneous transluminal aortoiliac stenting; Endovascular treatment of aortoiliac occlusive diseaseEndovascular reconstruction of aortic and iliac arterial obstruction: Balloon angioplasty may be performed initially to dilate the narrowed segment of the iliac artery. Subsequently, a stent delivery system is advanced over the wire and positioned across the lesion. The stent is deployed under fluoroscopic guidance to expand and scaffold the diseased artery, restoring blood flow. Vascular - iliac dedicated Stent - any brand | Procedure or surgery | Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease |
Primary outcome
Major Amputation
Time frame: through study completion, an average of 3 years
Amputation above the ankle
Cardiovascular Death
Time frame: through study completion, an average of 3 years
Death from cardiovascular disease
acute myorcardial infartion
Time frame: through study completion, an average of 3 years
According to the 4th definition of Myocardial infarction
3 secondary outcomes
Major Adverse Limb Events
Time frame: through study completion, an average of 3 years
Major adverse cardiovascular events
Time frame: through study completion, an average of 3 years
Death
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 20598474Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg. 2010 Nov;52(5):1376-83. doi: 10.1016/j.jvs.2010.04.080.
- Background: PubMed 28390920Groot Jebbink E, Holewijn S, Slump CH, Lardenoije JW, Reijnen MMPJ. Systematic Review of Results of Kissing Stents in the Treatment of Aortoiliac Occlusive Disease. Ann Vasc Surg. 2017 Jul;42:328-336. doi: 10.1016/j.avsg.2017.01.009. Epub 2017 Apr 6.
- Individual participant dataSharing planned: No. The anonymity and confidentiality of participants will be safeguarded. The patient will be entered without any reference to their name. The participant number will correspond to the clinical information in a separate database, which will only be used for the proposed objective after supervision by the PI and Supervisor. For analysis purposes, the participant number will be deleted. All information entered in the database will be constant in the clinical process. The results may be published in a scientific journal and/or congress. Rules of Ethical Conduct and Good Practices will be observed to ensure compliance with the precepts of the Declaration of Helsinki, the Convention on Human Rights and Biomedicine, the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practices.
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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.
Centro Hospitalar Universitário de São João, EPE
Porto, Portugal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortoiliac Atherosclerosis and Aortoiliac Occlusive Disease, run by Universidade do Porto at 2 sites in Portugal.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Amputation (time frame: through study completion, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260475, which also lists 2 linked publications.
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 15 Feb 2024.