Critical Limb IschemiaNCT01938872
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
An observational study of Critical Limb Ischemia, run by Ospedale San Donato at 1 site in Italy.
Trial summary
to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months 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?
- paclitaxel eluting balloon angioplasty in below-the-knee lesions
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Sep 2015
- How long will I take part?
- 12 Months
- 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 undergoing below-the-knee angioplasty with paclitaxel eluting balloon for critical limb ischemia
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, 1 recruiting
- Recruiting
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, 52100
Francesco Liistro, MD, francescoliistro@hotmail.com
Leonardo Bolognese, MD, FESC
About this study
to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months
- Conditions
- Critical Limb Ischemia
- Being tested
- paclitaxel eluting balloon angioplasty in below-the-knee lesions
- 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.
paclitaxel eluting balloon angioplasty in below-the-knee lesionsProcedure or surgery
Also called FREEWAY™ (Eurocor GmbH)
| Study group | Role | What they receive |
|---|---|---|
| PEB angioplasty | paclitaxel eluting balloon angioplasty in below-the-knee lesions Receives: Procedure: paclitaxel eluting balloon angioplasty in below-the-knee lesions |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Bolognese, MD, Ospedale San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938872
- Sponsor's protocol ID
- Arezzo010
- Status last verified
- Sep 2013
- First submitted
- 5 Sep 2013
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT01938872
- Acronym / sponsor ID
- Arezzo010
- Conditions
- Critical Limb Ischemia
- Keywords
- critical limb ischemia, drug-eluting balloon, restenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (estimated)
- First posted
- 10 Sep 2013 (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.
to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEB angioplasty | – | Procedure: paclitaxel eluting balloon angioplasty in below-the-knee lesionspaclitaxel eluting balloon angioplasty in below-the-knee lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing below-the-knee angioplasty with paclitaxel eluting balloon for critical limb ischemia
Key inclusion criteria (2 listed)
- age>18 years
- angiographic stenosis>50% or occlusion of one below-knee vessel
Key exclusion criteria (6 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 in below-the-knee lesionsAlso: FREEWAY™ (Eurocor GmbH) | Procedure or surgery | PEB angioplasty |
Primary outcome
angiographic binary restenosis
Time frame: 12 months
incidence of binary restenosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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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.
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 Critical Limb Ischemia, run by Ospedale San Donato 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: status not confirmed, as of the sponsor's last update on 10 Sep 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. 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?
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 10 Sep 2013.