Peripheral Artery Disease
Conditions
Keywords
Drug Eluting Balloon (DEB) technology, long SFA lesions disease
Brief 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. 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.
Interventions
None listed
Sponsors
Ettore Sansavini Health Science Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of primary patency | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| composite of all Major Adverse Events (MAE) | 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 |
| incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE) | within the first 24 months after percutaneous treatment | to assess the incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE) individual components through 24 months |
| clinical improvement as assessed by Rutherford Class changes | within 6, 12 and 24 months vs baseline | compare clinical improvement as assessed by Rutherford Class changes at 6, 12 and 24 months with respect to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| procedural success rate | at the end of percutaneous treatment | rate of procedural success i.e. complete revascularization in the absence of peri-procedural complications |
| walking capacity and quality of life | whithin 6, 12 and 24 months post-procedure vs. baseline | 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 |
| rate of instrumental restenosis | 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 |
Countries
Italy
Outcome results
None listed