Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug-coating balloon | Experimental | drug-coating balloon (Orchid) intervention |
|
| stent deployment | Active Comparator | metal bare stent intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.) | Device | for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency of claudicant patients | Claudicant patients (Rutherford C1-3), primary patency defined as PSVR(peak systolic velocity ratio) ≤2.4, absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months | 12 months after the index procedure |
| Salvage limb rate (for CLI patients) | Limb Salvage is defined as the freedom from secondary major amputation | 12 months after the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rutherford classification | 12 months | |
| ABI | Ankle Brachial index | 12 months |
| TcpO2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianming Guo, M.D. | Contact | +86 1314-636-9562 | guojianming@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongquan Gu, M.D. | Xuanwu hospital CMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gu Yong Quan | Recruiting | Beijing | Beijing Municipality | 100053 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stent (Maris,Medtronic.USA or Sinus/Supera, Germany) | Device | for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment. |
|
transcutaneous oxygen pressure |
| 12 months |
| Wagnar classification | incision healing information of Rutherford C5-6 patients | 12 months |
| Target vessel revascularization rate | frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel | 12 months |
| Index Limb Ischemia at 12-month Follow up | Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6. | 12 months |
| Major Adverse Events at 12-month Post Procedure | Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage. | 12 months |