Comparison of drug-eluting and plain balloon angioplasty in the treatment of stenosis of vascular access for dialysis
| ISRCTN | ISRCTN11414306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11414306 |
- Submission date
- 08/11/2022
- Registration date
- 01/12/2022
- Last edited
- 28/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Dialysis access circuit often develops stenosis and becomes unusable. Dilation of the stenosis using a wire and balloon inserted in the access is required to restore its patency. The aim of this study is to evaluate if adult patients with stenosis in dialysis vascular access would benefit from the use of a drug-eluting balloon.
Who can participate?
Adult patients with a clinically mature dialysis fistula already used for hemodialysis
What does the study involve?
Patients, who consent to participate, will receive additional treatment for the stenosis using a balloon catheter (drug-eluting balloon or plain balloon according to the randomization group). The drug-eluting balloon should slow down the recurrence of the stenosis and may prolong the usability of the access circuit. Participants will be asked to visit the facility for follow-up angiography at 3, 6, 9, and 12 months after the initial procedure or earlier if the access circuit develops stenosis (suspected by the physician or detected by ultrasound).
What are the possible benefits and risks of participating?
Any benefit from participation in this study is uncertain. Participation in this study does not involve additional risks compared to angioplasty with a "plain" balloon.
Where is the study run from?
Charles University in Prague (Czech Republic)
When is the study starting and how long is it expected to run for?
October 2018 to November 2021
Who is funding the study?
First Faculty of Medicine, Charles University and General University Hospital in Prague (Czech Republic)
Who is the main contact?
Associate Prof Andrea Burgetova, andrea.burgetova@vfn.cz (Czech Republic)
Contact information
Scientific
Department of Radiology
First Faculty of Medicine
Charles University and General University Hospital
Prague
12808
Czech Republic
 ORCID ID |
0000-0002-9975-2338 |
|---|---|
| Phone | +420224962232 |
| andrea.burgetova@vfn.cz |
Study information
| Study design | Single-center prospective single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 42729 PIS [Czech].pdf |
| Scientific title | Comparison of drug-eluting and plain balloon angioplasty in the treatment of stenosis of vascular access for dialysis |
| Study hypothesis | The use of a drug-eluting balloon for angioplasty with stenosis in vascular access for dialysis results in better primary patency rates than plain balloon angioplasty alone |
| Ethics approval(s) | Approved 18/10/2018, Ethics Committee of the General University Hospital in Prague (Na Bojišti 1, 3. Patro 128 08 Praha 2, Czech Republic; +420 224 964 131; eticka.komise@vfn.cz), ref: 1440/18 S-IV |
| Condition | Treatment with stenosis in the vascular access for dialysis in adult patients using percutaneous transluminal angioplasty |
| Intervention | The aim of this study was to evaluate if adult patients with stenosis in dialysis vascular access would benefit from the use of a drug-eluting balloon. The patients are referred from dialysis centers across the Czech Republic for angiography (and percutaneous transluminal angioplasty [PTA]) of the access circuit due to signs of its dysfunction. Exclusion and inclusion criteria are verified before and during the angiography. A follow-up angiography every 3 months up to 1 year (or up to the first PTA) after the index procedure is performed in both groups. Patients, who consent to participate, will receive additional treatment for the stenosis using a balloon catheter (drug-eluting balloon or plain balloon according to the permuted block randomization group). The drug-eluting balloon should slow down the recurrence of the stenosis. Participation in this trial does not involve additional risks compared to angioplasty with a "plain" balloon. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Resveratrol-excipient paclitaxel-coated balloon |
| Primary outcome measure | Primary patency rates measured using angiography and the need for repeated intervention at 3, 6, 9, 12 months or earlier if requested by the physician |
| Secondary outcome measures | Median time to target lesion re-intervention measured using medical records and angiography at 3, 6, 9, 12 months or earlier if requested by the physician |
| Overall study start date | 19/10/2018 |
| Overall study end date | 30/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 76 |
| Participant inclusion criteria | 1. Aged >18 years old 2. Life expectancy >1 year 3. Clinically mature dialysis fistula (AVG or AVF) already used for hemodialysis with adequate pump speed and dialysis efficacy for at least 4 consecutive sessions with the two-needle technique 4. Signs of fistula dysfunction (absent thrill, low flow, high venous pressure, high pulsatility, needling problems, abnormal pulsatility, abnormal auscultation, extremity edema, etc) 5. Hemodynamically significant (>50%) stenosis in juxta-anastomotic or outflow vein of AVF (excluding central veins defined as veins medial to the lateral margin of the first rib) or in the venous anastomosis, juxta-anastomotic segment or outflow vein in AVG (excluding central veins). |
| Participant exclusion criteria | 1. Access circuit thrombosis in the last year 2. History of graft infection 3. Prior use of a drug-eluting balloon catheter in the access circuit 4. In-stent restenosis in bare metal or covered stent 5. Angiography contraindications (e.g. severe contrast media allergy) 6. Two or more distinct significant stenoses in the access circuit |
| Recruitment start date | 19/10/2018 |
| Recruitment end date | 31/10/2020 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Prague 2
12808
Czech Republic
Sponsor information
University/education
First Faculty of Medicine
Kateřinská 1660/32
Prague 2
121 08
Czech Republic
| Phone | +420224962232 |
|---|---|
| martina.venhauerova@lf1.cuni.cz | |
| Website | www.lf1.cuni.cz |
"ROR" |
https://ror.org/024d6js02 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The First Faculty of Medicine of Charles University, Charles University in Prague - First Faculty of Medicine, First Faculty of Medicine, Charles University, First Faculty of Medicine Charles University, First Faculty of Medicine of Charles University, First Faculty of Medicine, Charles University in Prague, Univerzita Karlova 1. lékařská fakulta
- Location
- Czech Republic
Results and Publications
| Intention to publish date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 21/11/2022 | No | Yes | ||
| Results article | 14/12/2022 | 28/12/2022 | Yes | No |
Additional files
Editorial Notes
28/12/2022: Publication reference added.
02/12/2022: Internal review.
21/11/2022: Trial's existence confirmed by the Ethics Committee of the General University Hospital in Prague.
