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
Not provided
To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB Treatment Group | Experimental | Subjects treated with DCB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon | Device | After predilation, using drug-coated balloon catheter to cover the whole treated segment |
|
| Measure | Description | Time Frame |
|---|---|---|
| primary patency of target lesion in 6 months | Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention; 2) PSVR< 2.4 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Successful delivery to the target lesion, deployment, and retrieval at index procedure | Time of procedure |
| Clinical Success | The resumption of dialysis for at least one session after the index procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Liang, Bachelor | Contact | 13819565660 | jie.liang@zyloxmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhang | RenJi Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure. |
| Procedural Success | Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE). | 2 weeks |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |