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Critical Limb IschemiaPhase 4DEBATE-BTKNCT01558505

Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation

A Phase 4 study testing PEB and POBA in people with Critical Limb Ischemia, run by Leonardo Bolognese, MD at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Limb Ischemia
What is being tested?
PEB and POBA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 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
  • angiographic stenosis>50% or occlusion of one below-knee vessel

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Cardiovascular Department, Ospedale S.Donato

    Arezzo, AR, 52100

Other trials in Italy

About this study

Official title: Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.

Being tested
PEB, POBA
Keywords
critical limb ischemia, drug-eluting balloon, restenosis
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEBDevice

    paclitaxel-eluting balloon angioplasty

  • POBADevice

    conventional balloon angioplasty

Study groups in NCT01558505
Study groupRoleWhat they receive
standard PTAActive comparatorconventional balloon angioplasty
Receives: Device: POBA
Drug-eluting balloon angioplastyExperimentalpaclitaxel-eluting balloon angioplasty
Receives: Device: PEB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. angiographic binary restenosis

    incidence of binary restenosis

    Measured: 12 months

Secondary outcomes (3)

  1. major amputation

    incidence of major amputation

    Measured: 24 motnhs

  2. target lesion revascularization

    incidence of target lesion revascularization

    Measured: 24 months

  3. 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.

  1. First posted20 Mar 2012 (estimated)
  2. Study startNov 2010
  3. Primary completionSep 2012

Resources

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
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01558505
Sponsor's protocol ID
Arezzo005
Acronym
DEBATE-BTK
Status last verified
Jan 2013
First submitted
17 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 42573020

  • Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.

    PubMed 23797811

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PEB and POBA in people with Critical Limb Ischemia, 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 2 inclusion and 6 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 NCT01558505, 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.

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