NCT06253312 Treatment of TASC C and D Aortoiliac Lesions
| NCT ID | NCT06253312 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinical Centre of Serbia |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2024-05-01 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: The treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. 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 mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR. Aim: The aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions. Methodology: This is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data. Endpoints: Primary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.
Eligibility Criteria
Inclusion Criteria: * All patients (over 18 years of age) with a history of atherosclerotic peripheral arterial disease treated between 1st January 2015 and 1st January 2022 * All management strategies will be included (endovascular, hybrid, and open) Exclusion Criteria: * Patients who are pregnant * Patients who are under 18 years of age * Patients who have acute limb ischemia or acute on chronic ischemia * Non-atherosclerotic origin of disease: cyclist disease, trauma, dissection * Patients who were treated in conservative manner * Patients who underwent primary major amputation * Patients with limited life expectancy (less than 2 years)
Contact & Investigator
Joao Rocha Neves, MD PhD
STUDY DIRECTOR
Univeristy of Porto
Frequently Asked Questions
Who can join the NCT06253312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06253312 currently recruiting?
Yes, NCT06253312 is actively recruiting participants. Contact the research team at petar91goldy@gmail.com for enrollment information.
Where is the NCT06253312 trial being conducted?
This trial is being conducted at Belgrade, Serbia.
Who is sponsoring the NCT06253312 clinical trial?
NCT06253312 is sponsored by Clinical Centre of Serbia. The principal investigator is Joao Rocha Neves, MD PhD at Univeristy of Porto. The trial plans to enroll 900 participants.