The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.

NCT04861506 · tracked via the Priya Life Science China tracker

Sponsor

First People's Hospital of Hangzhou

Phase

Observational

Started

2021-04-01

Last updated

2025-09-15

Condition(s) studied

Thromboembolic DiseaseLower Extremity ProblemEndovascular TreatmentSafety IssuesEfficacy, Self

Investigational drug(s) / intervention(s)

endovascular treatment

endovascular treatment: All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods such as pharmacomechanical thrombectomy (PMT) and mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT）and/or percutaneous aspiration thrombectom (PAT) and/or CDT(catheter-directed thrombolysis) and/or percutaneous aspiration thrombectom (PAT) thrombolysis (CDT) for thrombus removal according to the characteristics of the lesions and hospital conditions.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria 1. Patients aged 18 years or older. 2. Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb. 3. Rutherford classification ranging from 3 to 5. 4. 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. 5. Mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT) and/or percutaneous aspiration thrombectomy(PAT) and/or CDT (catheter-directed thrombolysis) performed for thrombus removal. 6. 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. 7. Informed consent signed by patients. Exclusion criteria 1. Acute or subacute limb ischemia patients with Rutherford classification stage III. 2. Patients diagnosed with thromboangiitis obliterans. 3. Patients requring open surgery or hybrid operation after contrast radiography. 4. Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months. 5. Patients with known allergies to heparin, low molecular weight heparin, or contrast agents. 6. Patients at high risk for bleeding. 7. Pregnant or lactating women. 8. 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. 9. Patients enrolled in other clinical studies within the past 3 months. 10. Patients unwilling or refusing to sign the informed consent form. \-

Primary outcome measure(s)

Amputation-free survival — post-interventional 12months
The amputation-free survival after endovascular surgery
Adverse events at post-interventional 1months — post-interventional 1 months
the incidence of amputation, operation-related distal embolism, rethrombosis, acute renal failure and/or death.

Trial sites (1)

Facility	City	Region	Status
Fan xin	Hangzhou	Zhejiang	Recruiting

More First People's Hospital of Hangzhou trials in China

A Randomized, Double-Blind, Placebo-Controlled Trial of Fufei Huazhuo Tongluo Formula Combined With Standardized Medicine in Patients With Anti-Synthetase Syndrome-Associated Interstitial Lung Disease Starting soon

Electroacupuncture Regulation of Immune Cells in Herpes Zoster Recruiting

Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC Recruiting

Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy Starting soon

Chinese Multicenter Registry for Peutz-Jeghers Syndrome Starting soon

Other trials for the same condition

Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection Active, not recruiting

Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke After Endovascular Treatment Starting soon

DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease Recruiting

Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke Recruiting

The Efficacy and Safety of Endovascular Treatment for Acute Mild Basilar Artery Occlusion Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04861506 on ClinicalTrials.gov ↗ ← All trials in China