Clinical trial NCT01658540: Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: Drug Eluting Balloon (DEB) technology
long SFA lesions disease
Lead sponsor: Ettore Sansavini Health Science Foundation
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of primary patency
timeFrame: within the first 12 months after percutaneous treatment
Secondary outcomes:
measure: composite of all Major Adverse Events (MAE)
timeFrame: within the first 24 months after percutaneous treatment
measure: incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)
timeFrame: within the first 24 months after percutaneous treatment
measure: clinical improvement as assessed by Rutherford Class changes
timeFrame: within 6, 12 and 24 months vs baseline
Other outcomes:
measure: rate of instrumental restenosis
timeFrame: within the first 24 months after percutaneous treatment
measure: procedural success rate
timeFrame: at the end of percutaneous treatment
measure: walking capacity and quality of life
timeFrame: whithin 6, 12 and 24 months post-procedure vs. baseline
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Bari
country: Italy
facility: Anthea Hospital
city: Lecce
country: Italy
facility: Città di Lecce Hospital
city: Palermo
country: Italy
facility: Maria Eleonora Hospital, GVM Care & Research
city: Rapallo
country: Italy
facility: ICLAS Rapallo
city: Torino
country: Italy
facility: Maria Pia Hospital
Study officials:
affiliation: Maria Eleonora Hospital, GVM Care & Research
name: Antonio Micari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.