Peripheral Artery DiseaseDEB-SFA-LONGNCT01658540
Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular Disease
An observational study of Peripheral Artery Disease, run by Ettore Sansavini Health Science Foundation at 6 sites in Italy.
Trial summary
The primary purpose of this study is to assess safety and efficacy of the Drug Eluting Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic obstructive vascular disease in patients presenting with long lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 105 participants
- Where
- 6 sitesItaly
- Study dates
- Oct 2012to May 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients affected by lower extremities artery disease (LEAD) and referred to the participating centres for the endovascular treatment of de novo or restenotic lesions (no in stent restenosis) in the superficial femoral and proximal popliteal arteries will be considered for the study
Who may be able to join
- Documented ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4;
- Target lesion consists of a single solitary or multiple adjacent de novo or restenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm;
- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee);
- Life expectancy >1 year in the Investigator's opinion;
- Written informed consent.
Who cannot join
- Given the observational nature of the study, no study-specific but only clinical exclusion criteria will apply:
- Patient unwilling or unlikely to comply with FU schedule;
- Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure;
- Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
- Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure;
- 15 cm long inflow lesion (≥50% DS) or occlusion (any length) in the ipsilateral Iliac artery;
- Failure to successfully treat < 15 cm long inflow lesion in the ipsilateral Iliac artery
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Anthea Hospital
Bari, Bari, 70124
Maria Cecilia Hospital
Cotignola, Ravenna, 48010
Città di Lecce Hospital
Lecce, 73100
Maria Eleonora Hospital, GVM Care & Research
Palermo, 90141
ICLAS Rapallo
Rapallo
Maria Pia Hospital
Torino
About this study
Official title: Safety and Efficacy of the Drug Eluting Balloon (DEB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With Long Lesions: a Pilot Study
The primary purpose of this study is to assess safety and efficacy of the Drug Eluting Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic obstructive vascular disease in patients presenting with long lesions. As secondary aim this study is going to explore treatment effect on a number of procedural and clinical endpoints in order to collect information to design a future comparative effectiveness study.
Read the detailed description
The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Eluting Balloon (DEB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.
The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DEB currently available on the market.
- Conditions
- Peripheral Artery Disease
- Keywords
- Drug Eluting Balloon (DEB) technology, long SFA lesions disease
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of primary patency
Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and >50% restenosis in the treated lesion. Clinically driven TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure. Restenosis > 50% is defined by a peak systolic velocity ratio (PSVR) > 2.4.
Measured: within the first 12 months after percutaneous treatment
Secondary outcomes (3)
composite of all Major Adverse Events (MAE)
evaluate the incidence of the composite of all Major Adverse Events (MAE) through 24 months i.e. the first occurrence of any of the following: death from any cause, major target limb amputation, thrombosis at the target lesion site
Measured: within the first 24 months after percutaneous treatment
incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)
to assess the incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE) individual components through 24 months
Measured: within the first 24 months after percutaneous treatment
clinical improvement as assessed by Rutherford Class changes
compare clinical improvement as assessed by Rutherford Class changes at 6, 12 and 24 months with respect to baseline
Measured: within 6, 12 and 24 months vs baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionMay 2016
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ettore Sansavini Health Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Micari, MD, Principal investigator, Maria Eleonora Hospital, GVM Care & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658540
- Sponsor's protocol ID
- ESREFO09
- Acronym
- DEB-SFA-LONG
- Status last verified
- Sep 2016
- First submitted
- 31 Jul 2012
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Micari A, Vadala G, Castriota F, Liso A, Grattoni C, Russo P, Marchese A, Pantaleo P, Roscitano G, Cesana BM, Cremonesi A. 1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study. JACC Cardiovasc Interv. 2016 May 9;9(9):950-6. doi: 10.1016/j.jcin.2016.02.014.
PubMed 27151609
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Drug Eluting Balloon (DEB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With Long Lesions: a Pilot Study
- ClinicalTrials.gov ID
- NCT01658540
- Acronym / sponsor ID
- DEB-SFA-LONG / ESREFO09
- Conditions
- Peripheral Artery Disease
- Keywords
- Drug Eluting Balloon (DEB) technology, long SFA lesions disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ettore Sansavini Health Science FoundationUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Aug 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 primary purpose of this study is to assess safety and efficacy of the Drug Eluting Balloon (DEB) technology for the treatment of the Superficial Femoral Artery (SFA) ischemic obstructive vascular disease in patients presenting with long lesions. As secondary aim this study is going to explore treatment effect on a number of procedural and clinical endpoints in order to collect information to design a future comparative effectiveness study.
Detailed description
The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Eluting Balloon (DEB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.
The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DEB currently available on the market.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by lower extremities artery disease (LEAD) and referred to the participating centres for the endovascular treatment of de novo or restenotic lesions (no in stent restenosis) in the superficial femoral and proximal popliteal arteries will be considered for the study
Key inclusion criteria (5 listed)
- Documented ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4;
- Target lesion consists of a single solitary or multiple adjacent de novo or restenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm;
- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee);
- Life expectancy >1 year in the Investigator's opinion;
- Written informed consent.
Key exclusion criteria (7 listed)
- Given the observational nature of the study, no study-specific but only clinical exclusion criteria will apply:
- Patient unwilling or unlikely to comply with FU schedule;
- Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure;
- Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
- Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of primary patency
Time frame: within the first 12 months after percutaneous treatment
Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and >50% restenosis in the treated lesion. Clinically driven TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure. Restenosis > 50% is defined by a peak systolic velocity ratio (PSVR) > 2.4.
3 secondary outcomes
composite of all Major Adverse Events (MAE)
Time frame: within the first 24 months after percutaneous treatment
incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)
Time frame: within the first 24 months after percutaneous treatment
clinical improvement as assessed by Rutherford Class changes
Time frame: within 6, 12 and 24 months vs baseline
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 3 Oct 2016.
- Derived from this study: PubMed 27151609Micari A, Vadala G, Castriota F, Liso A, Grattoni C, Russo P, Marchese A, Pantaleo P, Roscitano G, Cesana BM, Cremonesi A. 1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study. JACC Cardiovasc Interv. 2016 May 9;9(9):950-6. doi: 10.1016/j.jcin.2016.02.014.
- Individual participant dataSharing planned: No
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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.
Antonio Micari, MD principal investigator
Maria Eleonora Hospital, GVM Care & Research
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Ettore Sansavini Health Science Foundation at 6 sites 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 5 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: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
rate of primary patency (time frame: within the first 12 months after percutaneous treatment). 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 NCT01658540, 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 3 Oct 2016.