Renal InsufficiencyDEB-after-CBNCT02578784
DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis
A study testing Angioplasty with drug-coated balloon and Angioplasty with plain old balloon in people with Renal Insufficiency, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Angioplasty with drug-coated balloon and Angioplasty with plain old balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dialysis fistula dysfunction requiring cutting balloon angioplasty
Who cannot join
- missing informed consent or unable to consent
- age < 18 years
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Radiology and Nuclear Medicine
Sankt Gallen, Canton of St. Gallen, 9007
Claas P Naehle, MD, +41-71-494 ext. 6628, claasphilip.naehle@kssg.ch
Lukas Hechelhammer, MD, +41-79-494 ext. 6627, lukas.hechelhammer@kssg.ch
About this study
Official title: Prospective, Randomized Trial on the Clinical Utility of Drug-coated Balloons After Angioplasty of Plain Old Balloon-resistent Dialysis Fistula Stenosis Using Cutting Ballons
The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting balloon (carrying with small knives on its surface) is performed, leading to a success rate of 89%. However, a problem is the high incidence of restenosis, which is about 40% for recurrent stenosis and over 10% in de novo stenosis.
The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is unknown.
Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses compared to the sole use of a cutting balloon.
- Conditions
- Renal Insufficiency
- Being tested
- Angioplasty with drug-coated balloon, Angioplasty with plain old balloon
- Keywords
- Dialysis
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty with drug-coated balloonDevice
Also called drug-coated balloon "Elutax"
Angioplasty with drug-coated balloon "Elutax" (Aachen Resonance, Germany)
Angioplasty with plain old balloonDevice
Also called balloon "Sterling"
Angioplasty with plain old balloon "Sterling" (BostonScientific, Switzerland)
| Study group | Role | What they receive |
|---|---|---|
| POBA-after-Cutting Balloon | Placebo comparator | After cutting balloon angioplasty, subsequent angioplasty is performed using a standard, non-coated balloon (plain old balloon, POBA). Receives: Device: Angioplasty with plain old balloon |
| DCB-after-Cutting Balloon | Active comparator | After cutting balloon angioplasty, subsequent angioplasty is performed using a drug-coated balloon (DCB) Receives: Device: Angioplasty with drug-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to worsening of dialysis fistula function [days]
Measured: one year
Secondary outcomes (3)
Change in lumen 12 months after PTA [mm]
aka "late lumen loss"
Measured: one year
Change in dialysis flow [ml/min.]
Measured: one year
Change in dialysis fistula flow [ml/min.]
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claas Philip Nähle, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578784
- Sponsor's protocol ID
- EKSG 15/086
- Acronym
- DEB-after-CB
- Status last verified
- Oct 2015
- First submitted
- 13 Oct 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial on the Clinical Utility of Drug-coated Balloons After Angioplasty of Plain Old Balloon-resistent Dialysis Fistula Stenosis Using Cutting Ballons
- ClinicalTrials.gov ID
- NCT02578784
- Acronym / sponsor ID
- DEB-after-CB / EKSG 15/086
- Conditions
- Renal Insufficiency
- Keywords
- Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting balloon (carrying with small knives on its surface) is performed, leading to a success rate of 89%. However, a problem is the high incidence of restenosis, which is about 40% for recurrent stenosis and over 10% in de novo stenosis.
The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is unknown.
Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses compared to the sole use of a cutting balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POBA-after-Cutting Balloon | Placebo comparator | Device: Angioplasty with plain old balloonAfter cutting balloon angioplasty, subsequent angioplasty is performed using a standard, non-coated balloon (plain old balloon, POBA). |
| DCB-after-Cutting Balloon | Active comparator | Device: Angioplasty with drug-coated balloonAfter cutting balloon angioplasty, subsequent angioplasty is performed using a drug-coated balloon (DCB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dialysis fistula dysfunction requiring cutting balloon angioplasty
Key exclusion criteria (3 listed)
- missing informed consent or unable to consent
- age < 18 years
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angioplasty with drug-coated balloonAlso: drug-coated balloon "Elutax"Angioplasty with drug-coated balloon "Elutax" (Aachen Resonance, Germany) | Device | DCB-after-Cutting Balloon |
| Angioplasty with plain old balloonAlso: balloon "Sterling"Angioplasty with plain old balloon "Sterling" (BostonScientific, Switzerland) | Device | POBA-after-Cutting Balloon |
Primary outcome
Time to worsening of dialysis fistula function [days]
Time frame: one year
3 secondary outcomes
Change in lumen 12 months after PTA [mm]
Time frame: one year
Change in dialysis flow [ml/min.]
Time frame: one year
Change in dialysis fistula flow [ml/min.]
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angioplasty with drug-coated balloon and Angioplasty with plain old balloon in people with Renal Insufficiency, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claas P Naehle, MD (+41-71-494 ext. 6628, claasphilip.naehle@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to worsening of dialysis fistula function [days] (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.