New hope for leg artery disease: minimally invasive procedures under study
NCT ID NCT04698304
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study looks at how well minimally invasive procedures (like balloons and stents) work for people with severe blockages in the leg arteries. It will track 1000 patients to see if these treatments restore blood flow and keep arteries open over time. The goal is to find the best approach for complex cases that are often left out of other studies.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,518 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with TASC C, D femoropopliteal lesions who undergoing endovascular treatment
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients over 18 years old 2. Patients with Rutherford classification range from 3 to 6 3. If patients with both lower limbs meeting the inclusion criteria, both side of limb can be selected for this study 4. The guide wire should pass through the lesion of femoropopliteal artery, and further endovascular treatment is performed. In this study, we did not limit the methods of the guide wire passing through the target lesion 5. If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled 6. For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery 7. Informed consent signed by patients Exclusion Criteria: 1. Patients who are unwilling or refuse to sign the informed consent form 2. Patients with acute and subacute lower extremity arterial thrombosis or arterial embolism 3. Patients with thromboangiitis obliterans 4. Patients with failure of endovascular treatment, and transferred to bypass surgery 5. Patients who underwent surgical atherectomy for common femoral artery occlusive lesions 6. Patients with known allergy to heparin, low molecular weight heparin and contrast agents 7. Patients who have been enrolled in other clinical trials in the past 3 months 8. Women during pregnancy and lactation 9. Patients with other diseases that may lead to difficulties in the trial or significantly shorten the life expectancy (\< 3 years), such as tumors, severe liver disease, cardiac insufficiency
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Renji Hospital
Shanghai, Shanghai Municipality, 200127, China