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The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in dialysis fistulae.
Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in dialysis fistulae and drug-eluting devices might be beneficial in this field as well.
In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.
The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting balloon | Experimental |
| |
| Conventional angioplasty | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional angioplasty | Device | Angioplasty with conventional balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| TLR | Target lesion revascularization, ie. re-intervention to the same lesion | 12 months |
| Occlusion of access | Any loss of dialysis access due to thrombosis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary assisted patency | Patency after endovascular reintervention due to restenosis or thrombosis | 12 months |
| Death | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarit Venermo, Prof | Helsinki University Hospital, dept of vascular surgery | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30182815 | Derived | Bjorkman P, Weselius EM, Kokkonen T, Rauta V, Alback A, Venermo M. Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas: A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study). Scand J Surg. 2019 Mar;108(1):61-66. doi: 10.1177/1457496918798206. Epub 2018 Sep 5. |
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| Angioplasty with drug-eluting balloon | Device | Angioplasty with drug-eluting balloon |
|
|
| ID | Term |
|---|---|
| D006083 | Graft Occlusion, Vascular |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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