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The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.
In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Balloon Angioplasty (COBA) | Active Comparator | Patients with lesions treated with conventional balloon angioplasty |
|
| Drug Eluting Balloon Angioplasty (DEB) | Experimental | Patients with lesions treated with Drug Balloon Angioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Transluminal Angioplasty (PTA) | Device | Angioplasty performed with the use of the novel paclitaxel eluting balloons |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography | 1 minute after the final balloon angioplasty |
| Primary patency | Angiographic visualization of a lesion with <50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary patency | Angiographicaly proven patency (<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access)of the treated lesion following one re-intervention procedure of any kind. | 1 year |
| Target lesion re-intervention (TLR)-free interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitrios Siablis, MD, PhD | University Hospital of Patras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patras University Hospital, Department of Radiology, Angiography Suite | Rio | Achaias | 26504 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25575743 | Derived | Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol. 2015 Mar;84(3):418-423. doi: 10.1016/j.ejrad.2014.11.037. Epub 2014 Dec 15. | |
| 22545894 |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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|
| Percutaneous Transluminal Angioplasty (PTA) | Device | Angioplasty performed with the use of conventional angioplasty balloons |
|
|
The time interval without any additional recanalization procedure within the area of the treated lesion, because of angiographic or/and clinical deterioration |
| 1 year |
| Major complications rates | Classified according to published international guidelines and reporting standards | Periprocedural and up to 1 year |
| Minor complications rates | Classified according to published international guidelines and reporting standards | Periprocedural and up to 1 year follow-up |
| Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1. |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |