Chronic Limb-threatening Ischemia, Endovascular Therapy
Conditions
Brief summary
This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.
Interventions
DEVICEEndovascular therapy
Endovascular treatment for critical limb threatening Ischemia
Sponsors
RenJi Hospital
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Zhejiang University
First Affiliated Hospital of Zhejiang University
Second Affiliated Hospital of Soochow University
Qingdao Haici Hospital
Chengdu University of Traditional Chinese Medicine
Fudan University
Huashan Hospital
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients \> 18 years of age; 2. patients with Chronic limb-threatening ischemia (CLTI); 3. patients with below-the-knee lesions undergoing endovascular treatment; 4. target limbs with certain WIfI stage; 5. patients voluntary and capable of follow-up; 6. informed consent. Definition of CLTI: A diagnosis of CLTI requires objectively documented atherosclerotic PAD in association with ischemic rest pain or tissue loss (ulceration or gangrene).
Exclusion criteria
1. Contraindication for antiplatelet , anticoagulant or thrombolytic agent; 2. Contrast agent allergy; 3. Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion; 4. Complications affecting surgical safety; 5. Major amputation was adopted to the target extremity; 6. The existence of aneurysm in the target vessels; 7. The existence of perforation, dissection or any other injury requiring intervention in the target vessels.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major amputation | 12 months | Major amputation was defined as any amputation above-the-ankle of the target limb. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rates | 1 week | Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation |
| Freedom from clinically driven target limb reintervention | 12 months | Clinically driven target limb reintervention was defined as any reintervention of ipsilateral infrapopliteal arteries for recurrent clinical symptoms. |
| Freedom from major adverse event | 12 months | Major adverse event was a composite of major amputation, all-cause death, and clinically driven target limb reintervention. |
| Quality of life | 12 months | The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score. |
| Hospitalization expenses | 12 months | Hospitalization costs for patients were evaluated |
| WIfI stages | 12 months | Before follow-up and during each follow-up, the Society for Vascular Surgery wound, ischemia, and foot Infection (WIfI) were evaluated classification system. |
| Amputation-free survival | 12 months | Survival without target limb major amputation. |
| Freedom from all-cause death | 12 months | Freedom from all-cause death. |
| Hospitalization time | 12 months | The length of hospital stay was evaluated |
| Primary sustained clinical improvement | 12 months | A decrease of at least 1 Rutherford grade without any reintervention. |
Countries
China
Outcome results
None listed