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

This study is currently recruiting participants.
Verified July 2013 by Ettore Sansavini Health Science Foundation
Sponsor:
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier:
NCT01658540
First received: July 31, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition
Peripheral Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Ettore Sansavini Health Science Foundation:

Primary Outcome Measures:
  • rate of primary patency [ Time Frame: within the first 12 months after percutaneous treatment ] [ Designated as safety issue: No ]
    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:
  • composite of all Major Adverse Events (MAE) [ Time Frame: within the first 24 months after percutaneous treatment ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: within the first 24 months after percutaneous treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 6, 12 and 24 months vs baseline ] [ Designated as safety issue: No ]
    compare clinical improvement as assessed by Rutherford Class changes at 6, 12 and 24 months with respect to baseline


Other Outcome Measures:
  • rate of instrumental restenosis [ Time Frame: within the first 24 months after percutaneous treatment ] [ Designated as safety issue: No ]
    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

  • procedural success rate [ Time Frame: at the end of percutaneous treatment ] [ Designated as safety issue: No ]
    rate of procedural success i.e. complete revascularization in the absence of peri-procedural complications

  • walking capacity and quality of life [ Time Frame: whithin 6, 12 and 24 months post-procedure vs. baseline ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 110
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658540

Contacts
Contact: Maria Cristina Jori, MD 0039 0545217031 mcjori@esrefo.org
Contact: Barbara Spagnolo, PhD 0039 0832229426 bspagnolo@esrefo.org

Locations
Italy
Casa di Cura Montevergine - Mercogliano Not yet recruiting
Mercogliano, AV, Italy
Contact: Maria Cristina Jori       mcjori@esrefo.org   
Principal Investigator: Paolo Cioppa, MD         
Maria Cecilia Hospital Recruiting
Cotignola, Ravenna, Italy, 48010
Contact: Giulia Schiavina       gschiavina@esrefo.org   
Principal Investigator: Chiara Grattoni, MD         
Anthea Hospital Not yet recruiting
Bari, Italy, 70124
Contact: Roberta Spirito       rspirito@esrefo.org   
Principal Investigator: Alfredo Marchese, MD         
Città di Lecce Hospital Recruiting
Lecce, Italy, 73100
Contact: Barbara Spagnolo, PhD       bspagnolo@esrefo.org   
Principal Investigator: Armando Liso, MD         
Maria Eleonora Hospital, GVM Care & Research Recruiting
Palermo, Italy, 90141
Contact: Clelia Iovino       ciovino@esrefo.org   
Sub-Investigator: Giuseppe Vadalà, MD         
Principal Investigator: Antonio Micari, MD         
ICLAS Rapallo Not yet recruiting
Rapallo, Italy
Contact: Annarita Zeoli       azeoli@esrefo.org   
Principal Investigator: Paolo Pantaleo, MD         
Maria Pia Hospital Recruiting
Torino, Italy
Contact: Annarita Zeoli       azeoli@esrefo.org   
Principal Investigator: Elvis Brscic, MD         
Sponsors and Collaborators
Ettore Sansavini Health Science Foundation
Investigators
Principal Investigator: Antonio Micari, MD Maria Eleonora Hospital, GVM Care & Research
  More Information

No publications provided

Responsible Party: Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier: NCT01658540     History of Changes
Other Study ID Numbers: ESREFO09
Study First Received: July 31, 2012
Last Updated: July 30, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Ettore Sansavini Health Science Foundation:
Drug Eluting Balloon (DEB) technology
long SFA lesions disease

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014