Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular Disease

Completed

• Conditions: Peripheral Artery Disease

• Registration Number: NCT01658540
• Lead Sponsor: Ettore Sansavini Health Science Foundation

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.

Study Timeline

• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-07
• Study Start: 2012-10
• Primary Completion: 2015-05
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Anthea Hospital; 🇮🇹 Bari, Italy

Città di Lecce Hospital; 🇮🇹 Lecce, Italy

Maria Eleonora Hospital, GVM Care & Research; 🇮🇹 Palermo, Italy

ICLAS Rapallo; 🇮🇹 Rapallo, Italy

Maria Pia Hospital; 🇮🇹 Torino, Italy

Maria Cecilia Hospital; 🇮🇹 Cotignola, Ravenna, Italy