Peripheral Arterial DiseaseDEBATE-ISRNCT01558531
Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis
An observational study of 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 versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-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?
- DEB and POBA
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- 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
Study population: Patients referring to our institution for peripheral artery disease
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, previously treated with nitinol stent implantation, with 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
- need for amputation
- angiographic evidence of stent fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.
- Conditions
- Peripheral Arterial Disease
- Being tested
- DEB, POBA
- 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.
DEBDevice
paclitaxel-eluting balloon angioplasty
POBADevice
conventional balloon angioplasty
| Study group | Role | What they receive |
|---|---|---|
| DEB | paclitaxel-eluting balloon angioplasty Receives: Device: DEB | |
| conventional PTA | historical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009) Receives: Device: POBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
angiographic binary re-restenosis
incidence of angiographic binary re-restenosis
Measured: 12 months
Secondary outcomes (3)
major amputation
incidence of major amputation
Measured: 24 months
stent thrombosis
incidence of stent thrombosis
Measured: 24 months
target lesion revascularization
incidence of target lesion revascularization
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 posted20 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2011
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558531
- Sponsor's protocol ID
- Arezzo006
- Acronym
- DEBATE-ISR
- Status last verified
- Feb 2015
- First submitted
- 17 Mar 2012
- Last updated
- 3 Feb 2015
- 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 42573020Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, Ricci L, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study. J Endovasc Ther. 2016 Feb;23(1):52-7. doi: 10.1177/1526602815614555. Epub 2015 Oct 28.
PubMed 26511896Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014 Feb;21(1):1-8. doi: 10.1583/13-4420R.1.
PubMed 24502477
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study
- ClinicalTrials.gov ID
- NCT01558531
- Acronym / sponsor ID
- DEBATE-ISR / Arezzo006
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, drug-eluting balloon, restenosis
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: slow enrollment
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Leonardo Bolognese, MDUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- First posted
- 20 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 versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB | – | Device: DEBpaclitaxel-eluting balloon angioplasty |
| conventional PTA | – | Device: POBAhistorical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referring to our institution for peripheral artery disease
Key inclusion criteria (3 listed)
- age>18 years
- intermittent claudication (Fontane III or IV)
- angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm, previously treated with nitinol stent implantation, with at least one below-knee vessel to the ankle
Key exclusion criteria (7 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 |
|---|---|---|
| DEBpaclitaxel-eluting balloon angioplasty | Device | DEB |
| POBAconventional balloon angioplasty | Device | conventional PTA |
Primary outcome
angiographic binary re-restenosis
Time frame: 12 months
incidence of angiographic binary re-restenosis
3 secondary outcomes
major amputation
Time frame: 24 months
stent thrombosis
Time frame: 24 months
target lesion revascularization
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- 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 26511896Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, Ricci L, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study. J Endovasc Ther. 2016 Feb;23(1):52-7. doi: 10.1177/1526602815614555. Epub 2015 Oct 28.
- Derived from this study: PubMed 24502477Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014 Feb;21(1):1-8. doi: 10.1583/13-4420R.1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 7 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: paused, as of the sponsor's last update on 3 Feb 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 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.
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?
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 re-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 NCT01558531, which also lists 3 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 3 Feb 2015.