Buerger disease
Conditions
Interventions
Hybrid group (Post-intervention):Hybrid treatment+Standardized medication after operation
Conservative group (Post-intervention):Conservative management
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject provides informed consent that is reviewed and approved by the Ethics Committee/ Institutional Review Board in West China Hospital; 2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits, and the subject is able and willing to comply with any required medication regimen; 3. The Rutherford classification of the lower extremity artery disease is from stage 4 to stage 6;
Exclusion criteria
Exclusion criteria: 1. The subjects had an intervention history of prior lower-extremity stenting or bypass (not including only balloon angioplasty); 2. The Buerger disease mainly involves the upper extremity of the subjects; 3. The subject has a known uncorrectable bleeding diathesis or active coagulopathy (platelet count < 80,000/µL); 4. The subject has CKD stage 4-5 (eGFR<30mL/min); 5. The subject has a known allergy or sensitivity to contrast media.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amputation-free survival(Primary ClinRO);pain-free working distance(Primary PCO); | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse limb events(Secondary ClinROs);quality of life EQ-5L(Secondary PCOs);Time back to work or study (Secondary PRO) (day); | — |
Countries
China
Contacts
Public ContactDing Yuan
West China Hospital, Sichuan University
Outcome results
None listed