An observational study in Aortoiliac Atherosclerosis, Aortoiliac Occlusive Disease and Aortoiliac Atherosclerosis With Gangrene, sponsored by Universidade do Porto. Not yet recruiting at 2 sites in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Universidade do Porto · Observational
Among 15 studies in Peripheral Arterial Disease with a site in Portugal — 6 open to participants now, 7 under way, 1 of them phase 3. Peripheral Arterial Disease · Portugal.
Among the 15 studies in Peripheral Arterial Disease with a site in Portugal, this one is one of 2 that started in 2024, is one of 4 observational ones, and was the 10th registered.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 500 is above the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →6 of the 15 studies in Peripheral Arterial Disease with a site in Portugal are open now.
A study can be open while its sites in Portugal have not opened yet or have stopped. Only those recruiting at a site in Portugal →
Of the 192 Peripheral Arterial Disease studies recruiting now, 138 (72%) set no upper age limit and 9 (5%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 5
First in 2012; this study’s year is marked. 2 started in 2024.
Median enrollment 150 across the 11 interventional studies, 690 across the 4 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
8 of 15 have an industry lead sponsor. The 10 most frequent:
Universidade do Porto is the lead sponsor of 174 studies on the registry; 53 are open to participants now.
Universidade do Porto has 3 studies filed under Peripheral Arterial Disease — fewer than ten, so there is no comparison to draw.
3 of the studies in Peripheral Arterial Disease with a site in Portugal that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06416644Hospital do Divino Espírito Santo de Ponta DelgadaThe PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) | 2026-12-31 |
| NCT06410521University of Trás-os-Montes and Alto DouroPersonalised Multicomponent Exercise Programme in Peripheral Arterial Disease | 2027-06 |
| NCT07582588University Institute of MaiaRecreational Team Handball Programme for Patients With Peripheral Arterial Disease | 2027-07-01 |
Among the 15 studies in Peripheral Arterial Disease with a site in Portugal, from their registry updates:
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
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).
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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).
Exclusion Criteria:
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
Procedure: Aortobifemoral bypass · Procedure: aortoiliac stenting
Open surgery with aortic and iliac reconstruction
Also known as: aortobiliac bypass
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
Also known as: Percutaneous transluminal aortoiliac stenting; Endovascular treatment of aortoiliac occlusive disease
Major Amputation
Amputation above the ankle
Time frame: through study completion, an average of 3 years
Cardiovascular Death
Death from cardiovascular disease
Time frame: through study completion, an average of 3 years
acute myorcardial infartion
According to the 4th definition of Myocardial infarction
Time frame: through study completion, an average of 3 years
Major Adverse Limb Events
Amputation above the ankle, arterial thrombosis of the limb, binary restenosis
Time frame: through study completion, an average of 3 years
Major adverse cardiovascular events
acute myocardial infarction; acute heart faillure, cardiovascular death, coronary reintervention
Time frame: through study completion, an average of 3 years
Death
Diagnosed by a physician
Time frame: through study completion, an average of 3 years
Intensive care unit instay
Intensive care unit instay - days)
Time frame: until 30 days
acute kidney injury (AKI)
AKI according to Riffle criteria
Time frame: until 30 days
Plan to share: 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.
Start is estimated for Mar 2024; primary completion for Aug 2024, 5 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.