Peripheral Arterial DiseasePhase 4DEBATE SFANCT01556542
Drug Eluting Balloon in peripherAl inTErvention SFA
A Phase 4 study testing paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation and nitinol stent implantation in people with Peripheral Arterial Disease, run by Leonardo Bolognese, MD at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation and nitinol stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Sep 2012
- Phase
- Phase 4
- 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
- age>18 years
- intermittent claudication(Fontane III or IV)
- angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
- at least one below-knee vessel to the ankle
Who cannot join
- allergy to Paclitaxel
- contraindication for combined antiplatelet treatment
- life expectancy <1 year
- hypersensitivity or contraindication to one of the study drugs
- lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.
- Conditions
- Peripheral Arterial Disease
- Being tested
- paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation, nitinol stent implantation
- Keywords
- peripheral arterial disease, drug-eluting balloon, restenosis
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantationDevice
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
nitinol stent implantationDevice
nitinol stent implantation
| Study group | Role | What they receive |
|---|---|---|
| standard PTA | Active comparator | nitinol stent implantation Receives: Device: nitinol stent implantation |
| DEB | Experimental | paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation Receives: Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
angiographic binary restenosis
incidence of binary restenosis
Measured: 12 months
Secondary outcomes (3)
major amputation
incidence of major amputation
Measured: 24 months
target lesion revascularization
incidence of target lesion revascularization
Measured: 24 months
vessel reocclusion
incidence of vessel reocclusion
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startNov 2010
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonardo Bolognese, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leonardo Bolognese, MD, Ospedale San Donato
- Investigators
- Francesco Liistro, MD, Principal investigator, Cardiovascular Department, San Donato Hospital, Arezzo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556542
- Sponsor's protocol ID
- Arezzo004
- Acronym
- DEBATE SFA
- Status last verified
- Jan 2013
- First submitted
- 13 Mar 2012
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.
PubMed 24239203
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
- ClinicalTrials.gov ID
- NCT01556542
- Acronym / sponsor ID
- DEBATE SFA / Arezzo004
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, drug-eluting balloon, restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Leonardo Bolognese, MDUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2012 (actual)
- First posted
- 16 Mar 2012 (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 evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard PTA | Active comparator | Device: nitinol stent implantationnitinol stent implantation |
| DEB | Experimental | Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantationpaclitaxel-eluting balloon angioplasty followed by nitinol stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age>18 years
- intermittent claudication(Fontane III or IV)
- angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
- at least one below-knee vessel to the ankle
Key exclusion criteria (5 listed)
- allergy to Paclitaxel
- contraindication for combined antiplatelet treatment
- life expectancy <1 year
- hypersensitivity or contraindication to one of the study drugs
- lack of consent
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 |
|---|---|---|
| paclitaxel-eluting balloon angioplasty followed by nitinol stent implantationpaclitaxel-eluting balloon angioplasty followed by nitinol stent implantation | Device | DEB |
| nitinol stent implantationnitinol stent implantation | Device | standard PTA |
Primary outcome
angiographic binary restenosis
Time frame: 12 months
incidence of binary restenosis
3 secondary outcomes
major amputation
Time frame: 24 months
target lesion revascularization
Time frame: 24 months
vessel reocclusion
Time frame: 24 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 29 Jan 2013.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
- Derived from this study: PubMed 24239203Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.
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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.
Francesco Liistro, MD principal investigator
Cardiovascular Department, San Donato Hospital, Arezzo, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation and nitinol stent implantation in people with Peripheral Arterial Disease, run by Leonardo Bolognese, MD at 1 site in Italy.
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 5 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 29 Jan 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
angiographic binary restenosis (time frame: 12 months). 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 NCT01556542, which also lists 2 linked publications.
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 29 Jan 2013.