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
Prospective multi-center single-blinded randomized controlled trial (RCT) investigating the safety and feasibility of the SELUTION SLR™ (Sustained Limus Release) 018 drug eluting balloon (DEB) for the treatment of failed AV fistula in renal dialysis patients. Patients will be randomised to either SELUTION SLR or POBA.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SELUTION SLR™ DEB | Experimental | Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. |
|
| Control Treatment | Active Comparator | POBA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SELUTION SLR™ DEB | Device | Subjects will receive standard high-pressure balloon angioplasty followed by local application of sirolimus with the SELUTION SLR™ 018 DEB (MedAlliance) of appropriate diameter and length to achieve full lesion coverage. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency of the treated lesion at 6 months post-intervention. | Primary patency: Defined as uninterrupted patency after the initial intervention with regular ongoing dialysis until symptomatic recurrent stenosis of the dialysis circuit, or thrombosis, mandating repeat treatment, or further surgical intervention of the access circuit or eventual failure/abandonment of the circuit with creation of alternative access for dialysis. This endpoint will be analysed cumulatively at 6 months and with time-to-event methods (e.g. Kaplan Meier) on extended follow-up period to 2 years. | 6 months |
| Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days | Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months. | Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months. | 6 months |
| Late lumen loss |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Athens | Athens | Greece | ||||
| University of Patras |
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
| Control Arm | Device | The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment. |
|
Late lumen loss (LLL) defined as the difference between the minimum lumen diameters after angioplasty and at the end of the 6-month follow-up angiogram.
| 6 months |
| Device Success | Device Success: Defined as successful balloon inflation of the SELUTION catheter for ≥2 minutes and retrieval of the catheter. | During Procedure |
| Anatomic success | Anatomic success: Defined as <30% residual stenosis diameter measured immediately after angioplasty. | Immediately after angioplasty |
| Clinical Success | Clinical Success: Defined as an improvement from baseline in the clinical or hemodynamic parameter (e.g., blood flow, venous pressures) that was the initial indicator of fistula dysfunction and the resumption of normal hemodialysis for a minimum of at least 1 session following the procedure. | 6 months |
| Binary Vessel Restenosis | Binary vessel restenosis: Angiographic restenosis rate defined as the incidence of stenosis ≥50% of the diameter of the reference vessel segment within the treated target lesion. | 6 months |
| Pátrai |
| Greece |
| Singapore General Hospital LTD | Singapore | Singapore |
| 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 |