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| Name | Class |
|---|---|
| Singapore Clinical Research Institute | OTHER |
| Boston Scientific Corporation | INDUSTRY |
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To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type.
The primary outcome measure is 6-month access circuit patency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-coated balloon | Experimental | Ranger drug-coated balloon will be used for all peripheral AVF stenosis. |
|
| Conventional balloon | Active Comparator | Conventional balloon will be used for all peripheral AVF stenosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angioplasty of all peripheral AVF stenosis | Device | All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Access circuit primary patency | Time to next clinically-driven intervention | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Access access circuit patency | Time to next clinically-driven intervention | 12 months |
| Access circuit assisted primary patency | Time to next access thrombosis or surgical intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arjunana Sarupraba | Contact | 6222 3322 | arjunana.sarupraba@sgh.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Recruiting | Singapore | Singapore |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 28, 2022 | Jul 10, 2024 |
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All are blinded except procedurist and protocol administrator.
| 6 and 12 months |
| Access circuit secondary patency | Time to access abandonment or surgical revision / declotting | 6 and 12 months |
| Procedural complication | Complication related to procedure | 12 months |
| Mortality | All cause mortality | 12 months and 5 years |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| 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 |
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