The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusion… (NCT04861506) | Clinical Trial Compass
RecruitingNot Applicable
The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
China400 participantsStarted 2021-04-01
Plain-language summary
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, More and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb were treated with endovascular procedures. Most guidelines suggests only stage I and stage IIa lesions are suitable for endovascular treatments. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients aged 18 years or older.
. Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb.
. Rutherford classification ranging from 3 to 5.
. Successful guidewire passage through the lesion of the femoropopliteal artery lesion, followed by further endovascular treatment. There are no restrictions will be implemented on the methods used for guidewire passage through the target lesion. The presence of thrombus must be confirmed via angiography and/or DSA and must be associated with occlusions of the lower extremity or ISR.
. The lower extremity artery must have a healthy runoff of at least 10 cm above the ankle with at least one healthy dorsalis pedis artery, medial plantar artery, or lateral plantar artery connecting to the digital artery below the ankle.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is looking at endovascular treatment for blocked arteries in the legs — how does my specific type of blockage compare to what this study is treating, and would my doctor consider me a potential candidate worth discussing?
2Since this trial has no assigned phase, which typically means it's evaluating a procedure rather than a new drug, what does that mean for what's already known about the safety of this endovascular approach compared to standard surgical options for my condition?
3The trial is measuring amputation-free survival and adverse events at one month after the procedure — what kinds of complications are most commonly seen with endovascular treatment of leg artery blockages, and how would my doctor manage those if they occurred?
4Are there standard treatments for acute or subacute leg artery occlusions — like open surgery or clot-dissolving medications — that my doctor would recommend first before considering an approach being studied in a trial like this?
5This trial is still actively recruiting, so if my doctor thinks it might be worth exploring, what would the follow-up schedule look like in the first month, and how would that fit with my work, travel, or caregiving responsibilities?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Acute or subacute limb ischemia patients with Rutherford classification stage III.
. Patients diagnosed with thromboangiitis obliterans.
. Patients requring open surgery or hybrid operation after contrast radiography.
. Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months.
. Patients with known allergies to heparin, low molecular weight heparin, or contrast agents.
. Patients at high risk for bleeding.
. Pregnant or lactating women.
. Patients with other conditions that may complicate study participation or significantly reduce life expectancy (\< 2 years), such as tumors, severe liver disease, and cardiac insufficiency.