Peripheral Vascular DiseasesNCT02750605
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
A study testing DEB and POBA in people with Peripheral Vascular Diseases, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study Results will be defined as: Limb salvage, Event-free survival… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- DEB and POBA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2016to 30 Aug 2022
- 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
- Critical limb ischemia. Rutherford class 4-6
- Crural disease, long lesions, more than 2 cm.
- Life expectancy > 1year
- > 18 years
Who cannot join
- Pregnancy
- Patients disapproval
- Allergy to drug or contrast
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study
Results will be defined as:
Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.
Primary endpoints:
Primary Patency at 12 months, TLR (clinical driven),
Secondary endpoints:
Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,
- Conditions
- Peripheral Vascular Diseases
- Being tested
- DEB, POBA
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEBDevice
Intervention with drug eluting balloon.
POBADevice
Intervention with old technology as comparison
| Study group | Role | What they receive |
|---|---|---|
| Drug eluting balloon angioplasty | Experimental | Intervention with DEB angioplasty in long lesions of crural arteries Receives: Device: DEB |
| Plain old balloon angioplasty | Active comparator | Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries Receives: Device: POBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of treated crural vessels
Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open.
Measured: 12 months
Clinical driven target lesion revascularization (TLR)
Porportion of patients that needs retreatment in in the monitored arterial segment
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 posted25 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Apr 2021
- Study completion30 Aug 2022
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 Vascular DiseasesStudies 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
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torbjorn Fransson, Skane University Hospital
- Investigators
- Torbjörn Fransson, Principal investigator, SUS, Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750605
- Sponsor's protocol ID
- TF3
- Status last verified
- Dec 2022
- First submitted
- 19 Jan 2016
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fransson T, Mohammed Y, Gottsater A, Resch T. Prospective Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus Conventional Balloon Angioplasty in Treating Below the Knee Arterial Lesions in Chronic Limb Threatening Ischemia: The CRURAL DEB Study. J Endovasc Ther. 2025 Nov 20:15266028251388746. doi: 10.1177/15266028251388746. Online ahead of print.
PubMed 41263159
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries
- ClinicalTrials.gov ID
- NCT02750605
- Acronym / sponsor ID
- TF3
- Conditions
- Peripheral Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 25 Apr 2016 (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 trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study
Results will be defined as:
Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.
Primary endpoints:
Primary Patency at 12 months, TLR (clinical driven),
Secondary endpoints:
Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug eluting balloon angioplasty | Experimental | Device: DEBIntervention with DEB angioplasty in long lesions of crural arteries |
| Plain old balloon angioplasty | Active comparator | Device: POBAIntervention with plain old balloon angioplasty POBA in long lesions of crural arteries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Critical limb ischemia. Rutherford class 4-6
- Crural disease, long lesions, more than 2 cm.
- Life expectancy > 1year
- > 18 years
Key exclusion criteria (3 listed)
- Pregnancy
- Patients disapproval
- Allergy to drug or contrast
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 |
|---|---|---|
| DEBIntervention with drug eluting balloon. | Device | Drug eluting balloon angioplasty |
| POBAIntervention with old technology as comparison | Device | Plain old balloon angioplasty |
Primary outcome
Primary patency of treated crural vessels
Time frame: 12 months
Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open.
Clinical driven target lesion revascularization (TLR)
Time frame: 12 months
Porportion of patients that needs retreatment in in the monitored arterial segment
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 30 Dec 2022.
- Derived from this study: PubMed 41263159Fransson T, Mohammed Y, Gottsater A, Resch T. Prospective Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus Conventional Balloon Angioplasty in Treating Below the Knee Arterial Lesions in Chronic Limb Threatening Ischemia: The CRURAL DEB Study. J Endovasc Ther. 2025 Nov 20:15266028251388746. doi: 10.1177/15266028251388746. Online ahead of print.
- 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.
Torbjörn Fransson principal investigator
SUS, Malmö
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEB and POBA in people with Peripheral Vascular Diseases, run by Skane University Hospital at 1 site in Sweden.
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 4 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: finished, as of the sponsor's last update on 30 Dec 2022. 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 Sweden. 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?
Primary patency of treated crural vessels (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 NCT02750605, 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 30 Dec 2022.