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

Peripheral Artery Disease Clinical Trial

— DEB-SFA-LONG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658540
• Other study ID #: ESREFO09
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: September 30, 2016
• Start date: October 2012
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Ettore Sansavini Health Science Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Vascular Diseases

Locations

Country	Name	City	State
Italy	Anthea Hospital	Bari
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Italy	Città di Lecce Hospital	Lecce
Italy	Maria Eleonora Hospital, GVM Care & Research	Palermo
Italy	ICLAS Rapallo	Rapallo
Italy	Maria Pia Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of instrumental restenosis	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	No
Other	procedural success rate	rate of procedural success i.e. complete revascularization in the absence of peri-procedural complications	at the end of percutaneous treatment	No
Other	walking capacity and quality of life	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	whithin 6, 12 and 24 months post-procedure vs. baseline	No
Primary	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.	within the first 12 months after percutaneous treatment	No
Secondary	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	within the first 24 months after percutaneous treatment	Yes
Secondary	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	within the first 24 months after percutaneous treatment	No
Secondary	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	within 6, 12 and 24 months vs baseline	No