Peripheral Artery Occlusive DiseaseDRECOREST1NCT03023098
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
A study testing Conventional PTA and Drug-eluting balloon in people with Peripheral Artery Occlusive Disease and Peripheral Artery Restenosis, run by Helsinki University Central Hospital at 1 site in Finland.
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 bypass vein grafts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Artery Occlusive Disease, Peripheral Artery Restenosis, Peripheral Artery Stenosis
- What is being tested?
- Conventional PTA and Drug-eluting balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2013to Nov 2016
- 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 venous bypass with stenosis warranting intervention
Who cannot join
- Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.
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 bypass vein grafts, 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.
- Conditions
- Peripheral Artery Occlusive Disease, Peripheral Artery Restenosis, Peripheral Artery Stenosis
- Being tested
- Conventional PTA, Drug-eluting balloon
- Keywords
- Restenosis, Drug-eluting balloon, Vein graft
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PTADevice
Also called PTA (percutaneous transluminal angioplasty), Balloon angioplasty
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
Drug-eluting balloonDevice
Also called DEB
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting balloon | Experimental | Not described Receives: Device: Drug-eluting balloon |
| Conventional PTA | Active comparator | Not described Receives: Device: Conventional PTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLR (Target lesion revascularization)
Any reintervention to the same lesion.
Measured: 12 months
Graft occlusion
Occlusion of the bypass graft
Measured: 0-12 months
Secondary outcomes (2)
Major amputation
Above or below knee amputation of the treated leg
Measured: 0-12 months
Death
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2013
- Primary completionNov 2016
- Study completionNov 2016
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 Peripheral Artery Occlusive DiseaseStudies 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, Outcomes assessor
- Enrolment
- 57 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, M.D., Ph.D., Study director, Helsinki University Hospital, Dept. of Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023098
- Sponsor's protocol ID
- DRECOREST1 - Jan 23rd 2013
- Acronym
- DRECOREST1
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bjorkman P, Kokkonen T, Alback A, Venermo M. Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study). Ann Vasc Surg. 2019 Feb;55:36-44. doi: 10.1016/j.avsg.2018.04.042. Epub 2018 Aug 6.
PubMed 30092443
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 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
- ClinicalTrials.gov ID
- NCT03023098
- Acronym / sponsor ID
- DRECOREST1 / DRECOREST1 - Jan 23rd 2013
- Conditions
- Peripheral Artery Occlusive Disease, Peripheral Artery Restenosis, Peripheral Artery Stenosis
- Keywords
- Restenosis, Drug-eluting balloon, Vein graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 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 bypass vein grafts.
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 bypass vein grafts, 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, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting balloon | Experimental | Device: Drug-eluting balloon |
| Conventional PTA | Active comparator | Device: Conventional PTA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any venous bypass with stenosis 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 PTAAlso: PTA (percutaneous transluminal angioplasty), Balloon angioplastyAfter passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon | Device | Conventional PTA |
| Drug-eluting balloonAlso: DEBAfter passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon | Device | Drug-eluting balloon |
Primary outcome
TLR (Target lesion revascularization)
Time frame: 12 months
Any reintervention to the same lesion.
Graft occlusion
Time frame: 0-12 months
Occlusion of the bypass graft
2 secondary outcomes
Major amputation
Time frame: 0-12 months
Death
Time frame: 0-12 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 18 Jan 2017.
- Derived from this study: PubMed 30092443Bjorkman P, Kokkonen T, Alback A, Venermo M. Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study). Ann Vasc Surg. 2019 Feb;55:36-44. doi: 10.1016/j.avsg.2018.04.042. Epub 2018 Aug 6.
- 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, M.D., Ph.D. study director
Helsinki University Hospital, Dept. of Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional PTA and Drug-eluting balloon in people with Peripheral Artery Occlusive Disease and Peripheral Artery Restenosis, run by Helsinki University Central Hospital at 1 site in Finland.
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 18 Jan 2017. 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 Finland. 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. 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 (Target lesion revascularization) (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 NCT03023098, 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 18 Jan 2017.