- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01658540
Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular Disease (DEB-SFA-LONG)
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Bari, Italy, 70124
- Anthea Hospital
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Lecce, Italy, 73100
- Città di Lecce Hospital
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Palermo, Italy, 90141
- Maria Eleonora Hospital, GVM Care & Research
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Rapallo, Italy
- ICLAS Rapallo
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Torino, Italy
- Maria Pia Hospital
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Ravenna
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Cotignola, Ravenna, Italy, 48010
- Maria Cecilia Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion criteria:
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of primary patency
Time Frame: within the first 12 months after percutaneous treatment
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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.
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within the first 12 months after percutaneous treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
composite of all Major Adverse Events (MAE)
Time Frame: within the first 24 months after percutaneous treatment
|
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
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within the first 24 months after percutaneous treatment
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incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)
Time Frame: within the first 24 months after percutaneous treatment
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to assess the incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE) individual components through 24 months
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within the first 24 months after percutaneous treatment
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clinical improvement as assessed by Rutherford Class changes
Time Frame: within 6, 12 and 24 months vs baseline
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compare clinical improvement as assessed by Rutherford Class changes at 6, 12 and 24 months with respect to baseline
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within 6, 12 and 24 months vs baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of instrumental restenosis
Time Frame: within the first 24 months after percutaneous treatment
|
the rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 post-index procedure and the rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) ≤2 and ≤3.5 at 12 months (6, and 24 if available) or at unscheduled visit, as evaluated by an independent core lab
|
within the first 24 months after percutaneous treatment
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procedural success rate
Time Frame: at the end of percutaneous treatment
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rate of procedural success i.e. complete revascularization in the absence of peri-procedural complications
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at the end of percutaneous treatment
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walking capacity and quality of life
Time Frame: whithin 6, 12 and 24 months post-procedure vs. baseline
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walking capacity as assessed by walking impairment questionnaire (WIQ) and quality of life (EQ5D questionnaire) at 6, 12 and 24 months post-procedure vs. baseline
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whithin 6, 12 and 24 months post-procedure vs. baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Antonio Micari, MD, Maria Eleonora Hospital, GVM Care & Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESREFO09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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