Vascular Access ComplicationDRECOREST2NCT03036241
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae)
A study testing Conventional angioplasty and Angioplasty with drug-eluting balloon in people with Vascular Access Complication and Restenosis, Vascular Graft, run by Helsinki University Central Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Access Complication, Restenosis, Vascular Graft, Dialysis Related Complications
- What is being tested?
- Conventional angioplasty and Angioplasty with drug-eluting balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2013to 28 Feb 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any dialysis access w/ native vessels warranting intervention
Who cannot join
- Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
About this study
Official title: Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (Dialysis Fistulae)
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.
Read the detailed description
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.
- Being tested
- Conventional angioplasty, Angioplasty with drug-eluting balloon
- Keywords
- drug-eluting balloon,, target lesion revascularization (TLR), restenosis
- Medical subject headings
- Graft Occlusion, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional angioplastyDevice
Also called PTA
Angioplasty with conventional balloon
Angioplasty with drug-eluting balloonDevice
Also called DEB
Angioplasty with drug-eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting balloon | Experimental | Not described Receives: Device: Angioplasty with drug-eluting balloon |
| Conventional angioplasty | Active comparator | Not described Receives: Device: Conventional angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLR
Target lesion revascularization, ie. re-intervention to the same lesion
Measured: 12 months
Occlusion of access
Any loss of dialysis access due to thrombosis
Measured: 12 months
Secondary outcomes (2)
Primary assisted patency
Patency after endovascular reintervention due to restenosis or thrombosis
Measured: 12 months
Death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start23 Jan 2013
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarit Venermo, Helsinki University Central Hospital
- Investigators
- Maarit Venermo, Prof, Principal investigator, Helsinki University Hospital, dept of vascular surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036241
- Sponsor's protocol ID
- DRECOREST2 - 23rd Jan 2013
- Acronym
- DRECOREST2
- Status last verified
- Jun 2017
- First submitted
- 19 Jan 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30182815
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (Dialysis Fistulae)
- ClinicalTrials.gov ID
- NCT03036241
- Acronym / sponsor ID
- DRECOREST2 / DRECOREST2 - 23rd Jan 2013
- Keywords
- drug-eluting balloon,, target lesion revascularization (TLR), restenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 23 Jan 2013 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 30 Jan 2017 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting balloon | Experimental | Device: Angioplasty with drug-eluting balloon |
| Conventional angioplasty | Active comparator | Device: Conventional angioplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any dialysis access w/ native vessels warranting intervention
Key exclusion criteria (1 listed)
- Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
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 |
|---|---|---|
| Conventional angioplastyAlso: PTAAngioplasty with conventional balloon | Device | Conventional angioplasty |
| Angioplasty with drug-eluting balloonAlso: DEBAngioplasty with drug-eluting balloon | Device | Drug-eluting balloon |
Primary outcome
TLR
Time frame: 12 months
Target lesion revascularization, ie. re-intervention to the same lesion
Occlusion of access
Time frame: 12 months
Any loss of dialysis access due to thrombosis
2 secondary outcomes
Primary assisted patency
Time frame: 12 months
Death
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Derived from this study: PubMed 30182815Bjorkman 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.
- Individual participant dataSharing planned: No
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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.
Maarit Venermo, Prof principal investigator
Helsinki University Hospital, dept of vascular surgery
Questions about this trial
What is this clinical trial studying?
A study testing Conventional angioplasty and Angioplasty with drug-eluting balloon in people with Vascular Access Complication and Restenosis, Vascular Graft, run by Helsinki University Central Hospital.
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 1 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: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLR (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03036241, which also lists 1 linked publication.
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 23 Jun 2017.