Peripheral Artery DiseasePhase 4NCT01969630
Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions
A Phase 4 study testing PEB and PES in people with Peripheral Artery Disease, run by Ospedale San Donato at 1 site in Italy.
Trial summary
To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- PEB and PES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Oct 2015
- 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
- intermittent claudication or critical limb ischemia
- de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries
- presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk
- presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis >70%)
Who cannot join
- life expectancy <1 year
- contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel
- need for major amputation (MA) at the time of enrolment
- Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major 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 determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty
- Conditions
- Peripheral Artery Disease
- Being tested
- PEB, PES
- Keywords
- femoropopliteal lesions
- 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.
PEBDevice
Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation
PESDevice
Systematic Paclitaxel eluting stent angioplasty
| Study group | Role | What they receive |
|---|---|---|
| PEB | Active comparator | PEB angioplasty plus provisional nitinol stent implantation Receives: Device: PEB |
| PES | Experimental | Systematic PES angioplasty Receives: Device: PES |
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 (1)
Composite of all cause mortality, major amputation and target lesion revascularization.
incidence of composite endpoint of all cause mortality, major amputation and target lesion revascularization.
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 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
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 Artery 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
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
- NCT01969630
- Sponsor's protocol ID
- Arezzo011
- Status last verified
- Oct 2013
- First submitted
- 21 Oct 2013
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Liistro F, Angioli P, Porto I, Ducci K, Falsini G, Ventoruzzo G, Ricci L, Scatena A, Grotti S, Bolognese L. Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. J Am Coll Cardiol. 2019 Jul 16;74(2):205-215. doi: 10.1016/j.jacc.2019.04.057.
PubMed 31296293
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions
- ClinicalTrials.gov ID
- NCT01969630
- Acronym / sponsor ID
- Arezzo011
- Conditions
- Peripheral Artery Disease
- Keywords
- femoropopliteal lesions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- First posted
- 25 Oct 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 determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEB | Active comparator | Device: PEBPEB angioplasty plus provisional nitinol stent implantation |
| PES | Experimental | Device: PESSystematic PES angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- intermittent claudication or critical limb ischemia
- de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries
- presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk
- presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis >70%)
Key exclusion criteria (4 listed)
- life expectancy <1 year
- contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel
- need for major amputation (MA) at the time of enrolment
- Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation
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 |
|---|---|---|
| PEBPaclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation | Device | PEB |
| PESSystematic Paclitaxel eluting stent angioplasty | Device | PES |
Primary outcome
angiographic binary restenosis
Time frame: 12 months
incidence of binary restenosis
1 secondary outcome
Composite of all cause mortality, major amputation and target lesion revascularization.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
- Derived from this study: PubMed 31296293Liistro F, Angioli P, Porto I, Ducci K, Falsini G, Ventoruzzo G, Ricci L, Scatena A, Grotti S, Bolognese L. Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. J Am Coll Cardiol. 2019 Jul 16;74(2):205-215. doi: 10.1016/j.jacc.2019.04.057.
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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?
A Phase 4 study testing PEB and PES in people with Peripheral Artery Disease, 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 4 inclusion and 4 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 25 Oct 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?
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?
On the ClinicalTrials.gov record for NCT01969630, 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 25 Oct 2013.