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

NCT01658540 | Completed

• 1 other identifier: ESREFO09
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 6

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.

Conditions

Peripheral Artery Disease

Keywords

Drug Eluting Balloon (DEB) technology; long SFA lesions disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• composite of all Major Adverse Events (MAE)

  within the first 24 months after percutaneous treatment

• incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)

  within the first 24 months after percutaneous treatment

• clinical improvement as assessed by Rutherford Class changes

  within 6, 12 and 24 months vs baseline

Other Outcomes (3)

• rate of instrumental restenosis

  within the first 24 months after percutaneous treatment

• procedural success rate

  at the end of percutaneous treatment

• walking capacity and quality of life

  whithin 6, 12 and 24 months post-procedure vs. baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Ettore Sansavini Health Science Foundation: lead

Study Sites (6)

Anthea Hospital

Bari, Bari, 70124, Italy

Location

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

Location

Città di Lecce Hospital

Lecce, 73100, Italy

Location

Maria Eleonora Hospital, GVM Care & Research

Palermo, 90141, Italy

Location

ICLAS Rapallo

Rapallo, Italy

Location

Maria Pia Hospital

Torino, Italy

Location

Related Publications (1)

• 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.

  PMID: 27151609 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Antonio Micari, MD

  Maria Eleonora Hospital, GVM Care & Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 7, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: October 3, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)