Efficacy of the EPIC Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) Lesions

Completed

• Conditions: Superficial Femoral Artery Stenosis; Atherosclerosis of Femoral Artery

• Registration Number: NCT01327950
• Lead Sponsor: Endovascular Consultoria Limitada

Brief Summary

This is a national, prospective, multi-center, non-randomized study to evaluate the long-term efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) lesions. A total of 100 patients will be included in approximately 10 sites. The study is designed to demonstrate the EPIC Nitinol Vascular Stent System is non- inferior to the published patency rates found in the literature. This non-inferiority will be established by proving that the true rate for the EPICTM Nitinol Vascular Stent System is higher than 82% minus a 10% delta.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Primary Completion: 2013-07
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patient presenting with a stenosis, re-stenosis after PTA (or adjunct therapy, excluding stents or stent grafts) or occlusion in the native superficial femoral artery (SFA), or SFA and proximal popliteal artery, suitable for primary stenting;
• Patient has a score from 2 to 5 following Rutherford classification;
• Patient is willing to comply with specified follow-up evaluations at the specified times;
• Patient is at least 18 years old; - Patient (or their legal representative) understands the nature of the procedure and provides written informed consent prior to enrollment in the study;
• Patient is eligible for treatment with the self-expanding EPIC Nitinol Vascular Stent System

Notes:

• If the patient has a contralateral peripheral lesion,this lesion can be treated as a non-target lesion before or after the study procedure
• If the patient has an ipsilateral iliac lesion,the lesion can be treated as a non target lesion, if the treatment is conducted before the target lesion treatment (during the same procedure or during a previous procedure), with a successful result defined as less than 30% residual diameter stenosis

Angiographic Inclusion Criteria:

• Target lesion(s) location is situated in the native SFA or SFA and proximal popliteal artery, with its most proximal point at least 1cm below the origin of the deep femoral artery and its distal point at least 3cm proximal to the knee joint, as measured by ipsilateral oblique view for proximal lesions and straight posterioanterior (PA) view for distal lesions;
• Evidence of at least 50% stenosis, re-stenosis after PTA (or adjunct therapy, excluding stents or stent grafts) or occlusion in the target lesion;
• Target lesion(s) total length is minimally 4cm and maximally 11cm and is amenable to treatment with a single stent;
• Target vessel diameter visually estimated is > 4mm and < 6.5mm
• There is angiographic evidence of at least one-vessel-runoff to the foot

General

Exclusion Criteria

• Presence of another stent or stent graft in the target vessel that was placed during a previous procedure;
• Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis;
• Previous bypass surgery in the same limb; - Necessity to treat target vessel with more than one EPICTM stent;
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated;
• Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion;
• Patients with known hypersensitivity to nickel-titanium;
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding;
• Life expectancy of less than twelve months;
• Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis > 30% or ipsilateral iliac treatment conducted after the target lesion procedure;
• Use of cutting balloon, scoring balloon, thrombectomy, arthrectomy, brachytherapy or laser devices during procedure;
• Any patient considered to be hemodynamically unstable at onset of procedure;
• Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period;
• Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (> 2.5mg/dl), recent MI or hemorrhagic stroke occurrence (both within 30 days).

Angiographic Exclusion Criteria:

• Inability to cross the target lesion by means of an exchangeable guidewire and to re-enter the true vessel lumen distal to the lesion site;
• Presence of a significant (minimally 50%) stenosis or occlusion in the ipsilateral common femoral artery;
• Aneurysm located at the level of the to-be-treated artery; - Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site; - Perforation (evidenced by extravasation of contrast medium), dissection or other injury of the access or target vessel requiring additional stenting or surgery prior to the start of the index procedure;
• Focal popliteal artery disease in the absence of femoral disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the long-term efficacy and integrity of the EPICTM Nitinol Vascular Stent System in SFA lesions.	12 months	The primary endpoint is primary patency rate at 12 months as determined by Duplex ultrasound at twelve months, defined as a target vessel with \<50% diameter stenosis at twelve months (systolic velocity ratio no greater than 2.4), without occurrence of target lesion revascularization between the index procedure and the twelve months follow-up control

Secondary Outcome Measures

Name	Time	Method
Initial arteriographic success	immediately following stent implantation (day 1)	Initial arteriographic success, defined as arteriographic evidence of improvement in luminal diameter to \<30% residual stenosis and/or an increase of at least 50% in luminal diameter immediately following stent implantation;
Primary patency rate	6 months	Primary patency rate at 6 months as determined by Duplex ultrasound at six months, defined as a target vessel with \<50% diameter stenosis at six months (systolic velocity ratio no greater than 2.4), without occurrence of target lesion revascularization between the index procedure and the twelve months follow-up control;
Major adverse event	1 year	- Major adverse event rate at 1 year, defined as: clinically- driven TLR, major amputation, all-cause mortality;
Increase of ABI	1 year	- Increase of Ankle-Brachial Index (ABI) at 1 year, defined as: an increase in ABI compared to baseline.
Technical Success	immediately following stent implantation (day 1)	- Technical success, defined as the ability to cross the target lesion with the device and deploy the stent as intended at the treatment site;

Trial Locations

Locations (6)

Hospital Santa Marcelina de São Paulo; 🇧🇷 São Paulo, SP, Brazil

Clinica Coris Medicina Avançada /Baia Sul Medical Center; 🇧🇷 Florianópolis, Santa Catarina, Brazil

Hospital Felicio Rocho; 🇧🇷 Belo Horizonte, MG, Brazil

Irmandade Santa Casa de Misericórdia de São Paulo; 🇧🇷 São Paulo, SP, Brazil

Instituto de Medicina Integral Professor Fernando Figueira (IMIP); 🇧🇷 Recife, PE, Brazil

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 São Paulo, SP, Brazil