Thromboangiitis Obliterans
Conditions
Interventions
Treatment group:Transcatheter intra-arterial infusion of Ginkgo biloba leaves injection
Control group:Transcatheter intra-arterial infusion of heparin sodium injection
Sponsors
First Clinical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 50 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in clinical study, fully understand and know the study and sign the informed consent; 2.Onset before age 50 years; 3.Current or recent tobacco use; 4.Distal extremity ischemia(resting pain, ischemic ulcers or gangrene with or without infection); 5.Thromboangiitis obliterans was diagnosed; 6.Consistent arteriographic findings in both clinically involved and non-involved limbs.
Exclusion criteria
Exclusion criteria: 1.With autoimmune disease, connective tissue disease or diabetes mellitus; 2.Cardiac ultrasound indicated mural thrombus and the lower limb artery embolism can not be completely excluded; 3.Clinical involved limbs have undergone arterial bypass or stem cell therapy within six months; 4.Patients with systemic inflammatory response syndrome caused by severe infection before surgery and had to undergo amputation to save their lives; 5.Patients with amputation (above metatarsal) of clinical involved or non-involved limbs before; 6.Patients with severe hepatic/renal insufficiency, septicemia/bacteremia, subacute bacterial endocarditis, or a serious disease or medical condition that may affect compliance with this study; 7.Patients with uncorrected bleeding disorders such as various active bleeding, thrombocytopenia, coagulation disorders, or menstruation; 8.Patients with known hypersensitivity to heparin or a history of type II heparin-induced thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular quality of life questionnaires; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perfusion with Laser Doppler Flowmetry;Major adverse physical events;Major adverse cardiovascular events;Total relief of rest pain;Incidence of serious adverse events;Healing of trophic lesions;Amputation of the affected limb above the ankle; | — |
Countries
China
Contacts
Public ContactXiong Jiang
First Clinical Center of Chinese PLA General Hospital
Outcome results
None listed